| A |
| Accredited Persons Programs |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
| Acoustics - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Acoustics - Premarket |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Acpuncture - Adverse Events |
Division of Postmarket Surveillance, OSB |
|
| Acpuncture - Compliance |
Division of Enforcement A, OC |
|
| Acupuncture - Premarket |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Adhesive (Band-Aids & Tissue) - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Adhesive (Band-Aids & Tissue) - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Adverse Events Reports - Database Information |
Division of Surveillance Systems, OSB |
|
| Adverse Events Reports - MDR Regulatory Information |
Division of Surveillance Systems, OSB |
|
| Adverse Events Reports - Specific Devices |
Division of Postmarket Surveillance, OSB |
|
| Advertising |
Promotion and Advertising Policy Staff, OC |
|
| Advisory Committees - General |
Division of Ethics and Management Operations, OMO |
|
| Advisory Committees - NMQAAC & TEPRSSC |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Advisory-Committees - Device Panels |
Office of the Director, ODE |
|
| After Action Reviews (AAR) |
Office of the Director, OSB |
|
| Air Cleaners - Compliance |
Division of Enforcement A, OC |
|
| Air Cleaners - Premarket |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Allergy Test |
Division of Immunology and Hematology Devices, OIVD |
|
| Alpha-Fetoprotein (AFP) |
Division of Immunology and Hematology Devices, OIVD |
|
| Analyte Specific Reagents |
Office of the Director, OIVD |
|
| Anesthesiology |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Anesthesiology - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Anesthesiology - Compliance |
Division of Enforcement B, OC |
|
| Anesthesiology - Premarket |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Aneurysm Clips - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch I, OSB |
|
| Aneurysm Clips - Compliance |
Division of Enforcement B, OC |
|
| Aneurysm Clips - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Angel Wings - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch I, OSB |
|
| Angel Wings - Premarket |
Division of Cardiovascular Devices, ODE |
|
| Angioplasty - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch I, OSB |
|
| Angioplasty Devices - Compliance |
Division of Enforcement B, OC |
|
| Angioplasty Devices - Premarket |
Division of Cardiovascular Devices, ODE |
|
240-276-4222
/ 240-276-4141
|
|
|
|
| Annual Report - CDRH |
CDRH, Office of the Director, FDA |
|
| Annual Report - Center |
Office of the Director, CDRH, OCD |
|
| Annual Report - OC |
Office of the Director, OC |
|
| Annual Report - OCER |
Office of the Director, OCER |
|
| Annual Report - ODE |
Office of the Director, ODE |
|
| Annual Report - OIVD |
Office of the Director, OIVD |
|
| Annual Report - OSB |
Office of the Director, OSB |
|
| Annual Report - OSEL |
Office of the Director, OSEL |
|
| Anti-microbial Susceptibility Testing (AST) |
Associate Director for Bacteriology, OIVD |
|
| Aortic Valves |
Division of Cardiovascular Devices, ODE |
|
| APNEA Detector - Adverse Events |
Division of Postmarket Surveillance, OSB |
|
| APNEA Detector - Compliance |
Division of Enforcement B, OC |
|
| APNEA Detector - Device Evaluation |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| APNEA Detector - Educational |
Division of Device User Programs and Systems Analysis, OCER |
|
| APNEA Detector - Premarket |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| APNEA Detector - Scientific/Technical |
Division of Imaging and Applied Mathematics, OSEL |
|
| Appeals |
Office of the Director, CDRH, OCD |
|
| Arterial Grafts - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Arterial Grafts - Epidemiology |
Division of Postmarket Surveillance, OSB |
|
| Arterial Grafts - Premarket |
Division of Cardiovascular Devices, ODE |
|
| Artificial Disc - Adverse Events |
Division of Surveillance Systems, OSB |
|
| Artificial Disc - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Assistance to Manufactures |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
| Assistive Listening Devices - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Assistive Listening Devices - Premarket |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Audiometer - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Audiometer - Premarket |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Auditory Trainer |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Automated PAP Smear Preparation Devices and Readers |
Associate Director for Hematology, OIVD |
|
| B |
| Bacteriology |
Associate Director for Bacteriology, OIVD |
|
| Benign Prostatic Hyperplasia (BPH) |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Biocompatibility |
Division of Biology, OSEL |
|
| Biofeedback - Compliance |
Division of Enforcement B, OC |
|
| Biofeedback - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Bioinformatics Board |
Office of the Director, CDRH, OCD |
|
| Biological Risk Assessment |
Division of Biology, OSEL |
|
| Biology (Cell, Molecular, Vascular) |
Division of Biology, OSEL |
|
| Biomarkers |
Office of the Director, OIVD |
|
| Bioresearch Monitoring |
Division of Bioresearch Monitoring, OC |
|
| Biostatistics |
Division of Biostatistics, OSB |
|
| Biostimulator (Laser) - Compliance |
Division of Enforcement B, OC |
|
| Biotechnology - Biosensors |
Division of Biology, OSEL |
|
| Bioterrorism |
Office of the Director, CDRH, OCD |
|
| Bladder Cancer |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Blood Glucose - Premarket |
Division of Chemistry and Toxicology Devices, OIVD |
|
| Blood Glucose - Scientific/Technical |
Standards Management Staff, OSEL |
|
| Blood Transfusion Devices - Compliance |
Division of Enforcement A, OC |
|
| Blood Transfusion Devices - Premarket |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Bone Cement - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Bone Cement - Compliance |
Division of Enforcement B, OC |
|
| Bone Cement - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Bone Densitometers - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Bone Densitometers - Patient Labeling |
Division of Device User Programs and Systems Analysis, OCER |
|
| Bone Densitometers - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Bone Densitometers - Scientific/Technical |
Division of Imaging and Applied Mathematics, OSEL, FDA |
|
| Bone Fixation Appliance - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Bone Fixation Appliance - Scientific/Technical |
Division of Chemistry and Materials Science, OSEL |
|
| Bone Graft Substitutes - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Bone Graft Substitutes - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Bone Growth Stimulators - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Bone Growth Stimulators - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Breast Implants - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Breast Implants - Compliance |
Division of Enforcement A, OC |
|
| Breast Implants - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Breathing Circuits - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Breathing Circuits - Compliance |
Division of Enforcement B, OC |
|
| Breathing Circuits - Device Evaluation |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Breathing Circuits - Educational Information |
Division of Device User Programs and Systems Analysis, OCER |
|
| Breathing Circuits - Premarket |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Budget - Appropriations & Formulation |
Division of Planning, Analysis and Finance, OSM, OMO |
|
| Budget - CDRH Execution |
Division of Planning, Analysis and Finance, OSM, OMO |
|
| C |
| Calibration of Densitometers and Sensitometers |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Calibration of Electronic Equipment |
Division of Electrical and Software, OSEL |
|
| Carbon Fiber Materials used in X-ray Systems |
Division of Imaging and Applied Mathematics, OSEL |
|
| Carcinogenesis |
Division of Biology, OSEL |
|
| Cardiac Biomarkers |
Division of Chemistry and Toxicology Devices, OIVD |
|
| Cardiac Occluders - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch I, OSB |
|
| Cardiac Occluders - Premarket |
Division of Cardiovascular Devices, ODE |
|
| Cardiac Pacemakers - Adverse Events |
Division of Postmarket Surveillance, OSB |
|
| Cardiac Pacemakers - Premarket |
Division of Cardiovascular Devices, ODE |
|
| Cardiovascular Devices - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch I, OSB |
|
| Cardiovascular Devices - Compliance |
Division of Enforcement B, OC |
|
| Case Management |
Division of Enforcement I, OC |
|
| Catheters - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch I, OSB |
|
| Catheters - Compliance |
Division of Enforcement B, OC |
|
| Catheters - Premarket (Cardiac Ablation) |
Division of Cardiovascular Devices, ODE |
|
| Catheters - Premarket (Interventional) |
Division of Cardiovascular Devices, ODE |
|
| Cathode Ray Tube (CRT) |
Division of Mammography Quality and Radiation Programs, OCER |
|
| CDC Activities |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Cell Phones - Bio-Effects |
Division of Biology, OSEL |
|
| Cell Phones - Electromagnetic Interference |
Division of Physics, OSEL |
|
| Cell Phones - Specific Absorpiton Rate (SAR) |
Division of Physics, OSEL |
|
| Ceramics Chemistry and Properties |
Division of Chemistry and Materials Science, OSEL |
|
| Certificate for Export |
Division of Risk Management, OC |
|
| Chemistry Issues |
Division of Chemistry and Materials Science, OSEL |
|
| Chemistry Products |
Division of Chemistry and Toxicology Devices, OIVD |
|
| Chiropractic Products - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Cholesterol Testing |
Associate Director for Chemistry, OIVD |
|
| Class II - Petitions for Exemptions |
Program Operations Staff, ODE |
|
| Classification ODE Issues |
Program Operations Staff, ODE |
|
| Clinical Laboratory Improvements Amendments (CLIA) |
Associate Director for Chemistry, OIVD |
|
| Clinical Trials - Reporting Complaints - Medical Devices |
Division of Bioresearch Monitoring, OC |
|
| Coagulation Testing and Monitors |
Associate Director for Hematology, OIVD |
|
| Cochlear Implant - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Cochlear Implant - Compliance |
Division of Enforcement A, OC |
|
| Cochlear Implant - Premarket |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Collagen |
Division of General, Restorative and Neurological Devices, ODE |
|
| Color Additives - Petitions |
Center for Food Safety and Applied Nutrition, Division of Petition Control, FDA |
|
| Color Additives - Premarket |
Program Operations Staff, ODE |
|
| Compassionate Use |
Program Operations Staff, ODE |
|
| Computational Intelligence Technology |
Division of Imaging and Applied Mathematics, OSEL |
|
| Computed Tomography (CT) - Adverse Events |
Division of Postmarket Surveillance, OSB |
|
| Computed Tomography (CT) - Compliance |
Division of Enforcement B, OC |
|
| Computed Tomography (CT) - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Computed Tomography (CT) - Scientific/Technical |
Division of Imaging and Applied Mathematics, OSEL, FDA |
|
| Computer Aided Diagnostics (CADx) |
Division of Imaging and Applied Mathematics, OSEL, FDA |
|
| Computer Report Summaries - MDR |
Division of Surveillance Systems, OSB |
|
| Computer Software - Review of Submissions |
Division of Electrical and Software, OSEL |
|
| Computer Support |
Office of Information Technology CDRH (OITCDRH), FDA |
|
| Computerized Medical Devices |
Division of Electrical and Software, OSEL |
|
| Computers in Cardiovascular Medicine |
Division of Cardiovascular Devices, ODE |
|
| Computers in Medicine |
Division of Electrical and Software, OSEL |
|
| Condoms - AIDS |
Office of the Director, CDRH, OCD |
|
| Condoms - Compliance |
Division of Enforcement A, OC |
|
| Condoms - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Conference of Radiation Control Program Directors |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Conference Room Management - 1350 Piccard 100U, V, X |
Office of the Director, OSB |
|
| Conference Room Management - 1350 Piccard 120S |
Staff College, OCER |
|
| Conference Room Management - 9200 Corporate Blvd. |
Office of Device Evaluation, ODE |
|
| Conference Room Management - 2098 Oak Grove Rm. 159, 357 |
Employee Resource Information Center (ERIC), FDA |
|
| Conference Room Management - White Oak Engineering/Physics |
Office of the Director, OSEL |
|
| Conflict of Interest |
Division of Ethics and Management Operations, OMO |
|
| Congressional Affairs |
Office of the Director, CDRH, OCD |
|
| Consumer Affairs |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
| Consumer Product Safety Commission |
CPSC, FDA |
|
| Contact Lenses |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Continuity of Operations Plan (COOP) |
Office of the Director, CDRH, OCD |
|
| Contracts |
Division of Planning, Analysis and Finance, OSM, OMO |
|
| Cooperative Research and Development Agreement (CRADA) |
Office of the Director, CDRH, OCD |
|
| Cordless Telephones |
Division of Enforcement B, OC |
|
| Correspondence (CDRH) |
Executive Secretariat, CDRH, OCD |
|
| Cosmetic Devices |
Division of General, Restorative and Neurological Devices, ODE |
|
| Cosmetic Surgery Tools and Implants - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Cosmetic Surgery Tools and Implants - Premarket |
Division of General , Restorative and Neurological Devices,Orthopedic Spine, ODE |
|
| Counterterrorism & Emergency Operations Coordinator |
Office of the Director, CDRH, OCD |
|
| Critical Path |
Office of the Director, OIVD |
|
| CRS (Congressional Research Service Inquiries) |
Division of Ethics and Management Operations, OMO |
|
| Cryosurgery - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Cryosurgery - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| D |
| Database - Oracle and Web |
Office of Information Technology CDRH (OITCDRH), FDA |
|
| De Novo Classification (section 513(f)(2)) |
Program Operations Staff, ODE |
|
| Deep Brain Stimulator - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Deep Brain Stimulator - Compliance |
Division of Enforcement B, OC |
|
| Deep Brain Stimulator - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Defibrilator - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Defibrilator - Compliance |
Division of Enforcement B, OC |
|
| Defibrillator - Premarket |
Division of Cardiovascular Devices, ODE |
|
| Defibrillator - User Problems |
Division of Device User Programs and Systems Analysis, OCER |
|
| Dental Bone Grafting Materials |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Dental - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch I, OSB |
|
| Dental Amalgams |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Dental Restorative Materials |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Design Control |
Division of Electrical and Software, OSEL |
|
| Device Advice |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
| Device Determinations & Labeling |
Office of the Director, OC |
|
| Device Labeling |
Office of the Director, OC |
|
| Device Listing |
Regulatory Policy and Systems Branch, OC |
|
| Device Patient Labeling |
Division of Device User Programs and Systems Analysis, OCER |
|
| Device User Interface |
Division of Device User Programs and Systems Analysis, OCER |
|
| Diabetes (In Vitro Monitoring) |
Division of Chemistry and Toxicology Devices, OIVD |
|
| Diabetes Devices - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Diabetic Devices - Compliance |
Office of the Director, OIVD |
|
| Diabetic Devices - Premarket |
Division of Chemistry and Toxicology Devices, OIVD |
|
| Diagnostic Technologies (Optical and Electromagnetic) |
Division of Physics, OSEL |
|
301-796-2494
/ 301--796-2472
|
|
|
|
| Diagnostic Test Kits |
Office of the Director, OIVD |
|
| Dialysis - Device |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Dialysis or Dialyzer - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Dialysis or Dialyzer - Compliance |
Division of Enforcement A, OC |
|
| Dialysis or Dialyzer - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Dialysis or Dialyzer - User Problems |
Division of Device User Programs and Systems Analysis, OCER |
|
| Diathermy |
Division of Physics, OSEL |
|
| Diathermy - Musculoskeletal Therapy Use |
Division of General, Restorative and Neurological Devices, ODE |
|
| Digital Radiology - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch I, OSB |
|
| Digital Radiology - Compliance |
Division of Enforcement B, OC |
|
| Digital Radiology - OCER |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Digital Radiology - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Digital Radiology - Scientific/Technical |
Division of Imaging and Applied Mathematics, OSEL, FDA |
|
| Disc Prosthesis - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Disc Prosthesis - Premarket |
Division of General , Restorative and Neurological Devices,Orthopedic Spine, ODE |
|
| Disinfectants |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Disinfectants - Compliance |
Division of Enforcement A, OC |
|
| Disposal Device (Anesthesiology) |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Dispute Resolution |
Office of the Director, CDRH, OCD |
|
| Document Control |
Program Operations Staff, ODE |
|
| Document Mail Center (DMC) |
Program Operations Staff, ODE |
|
| Drug Abuse Screening - Compliance |
Deputy Office Director, OIVD |
|
| Drug Abuse Screening - Device Evaluation |
Division of Chemistry and Toxicology Devices, OIVD |
|
| Drug Abuse Screening - Premarket |
Associate Director for Toxicology, OIVD |
|
| Drug Testing |
Associate Director for Toxicology, OIVD |
|
| Dura Mater - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Dura Mater - Compliance |
Division of Enforcement B, OC |
|
| Dura Product |
Division of General, Restorative and Neurological Devices, ODE |
|
| E |
| EEO |
Office of Shared Services, FDA |
|
| Electric Company Power Lines |
Division of Physics, OSEL |
|
| Electrical Blankets |
Division of Physics, OSEL |
|
| Electrical Engineering |
Division of Electrical and Software, OSEL |
|
| Electrical Safety |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Electrical Stimulation Devices |
Division of Physics, OSEL |
|
| Electro Convulsive Therapy - Device Evaluation |
Division of General, Restorative and Neurological Devices, ODE |
|
| Electro Convulsive Therapy - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Electro Convulsive Therapy - Research |
Division of Biology, OSEL |
|
| Electro Convulsive Therapy - Scientific/Technical |
Division of Biology, OSEL |
|
| Electro Optics |
Division of Physics, OSEL |
|
| Electroencephalograph (EEG) |
Division of General, Restorative and Neurological Devices, ODE |
|
| Electromagnetic Compatibility (EMC) |
Division of Physics, OSEL |
|
| Electromagnetic Compatibility (EMC) of Medical Devices |
Division of Physics, OSEL |
|
| Electromagnetic Interference (EMI) of Medical Devics |
Division of Physics, OSEL |
|
| Electromagnetic Metrology |
Division of Physics, OSEL |
|
| Electronic Muscle Stimluator (EMS) - Device Evaluation |
Division of General, Restorative and Neurological Devices, ODE |
|
| Electronic Muscle Stimulator (EMS) - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Electronic Muscle Stimulator (EMS) - Compliance |
Division of Enforcement B, OC |
|
| Electronic Muscle Stimulator (EMS) - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Electronic Records and Signatures |
Division of Enforcement B, OC |
|
| Electronic Submissions |
CIO Office of Information, CDRH, CIO Office of Information Technology |
|
| Electronic Submissions - MDR |
Division of Surveillance Systems, OSB |
|
| Electrophysics |
Division of Physics, OSEL |
|
| Electrostatic Discharge |
Division of Imaging and Applied Mathematics, OSEL |
|
| Emergency Operations |
Office of the Center Director, CDRH |
|
| Endoscopes - Compliance |
Division of Enforcement A, OC |
|
| Endoscopes - Premarket (Accessories) |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Endoscopes - Premarket (GI and Urology) |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Endoscopes - User Problems (Washers) |
Division of Device User Programs and Systems Analysis, OCER |
|
| Endoscopes, Washers - Compliance |
Division of Enforcement A, OC |
|
| Endoscopes, Washers - Device Evaluation |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Endoscopes, Washers - User Problems |
Division of Device User Programs and Systems Analysis, OCER |
|
| Epidemiology |
Division of Postmarket Surveillance, OSB |
|
| Epilators (Hair Removal Device) |
Division of General, Restorative and Neurological Devices, ODE |
|
| Epilators (hair removal device) - Consumer Contact |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
| Ethics |
Division of Ethics and Management Operations, OMO |
|
| Ethylene Oxide (ETO) - Compliance |
Division of Enforcement A, OC |
|
| Ethylene Oxide (ETO) - Premarket |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Ethylene Oxide (ETO) - Scientific/Technical |
Division of Biology, OSEL |
|
| ETO (Ethylene Oxide) - Compliance |
Division of Enforcement A, OC |
|
| ETO (Ethylene Oxide) - Device Evaluation |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| European Union (EU) |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
| Evaluation of Automatic Class III Designations (deNovo) |
Program Operations Staff, ODE |
|
| Excimer Laser (Opthalmic) - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Excimer Lasers (Ophthalmic) - Compliance |
Division of Enforcement A, OC |
|
| Excimer Lasers (Ophthalmic) - Device Evaluation |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Excimer Lasers (Ophthalmic) - Premarket |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Excimer Lasers (Ophthalmic) - Scientific/Technical |
Division of Physics, OSEL |
|
| Exercise Equipment - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Exercise Equipment - Compliance |
Division of Enforcement B, OC |
|
| Exercise Equipment - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Export Issues |
Division of Risk Management, OC |
|
| Extended Wear Contact Lens - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Extended Wear Contact Lens - Compliance |
Division of Enforcement A, OC |
|
| Extended Wear Contact Lens - Premarket |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| F |
| Facilities |
Division of Ethics and Management Operations, OMO |
|
| FDA Consumer Assistance |
FDA |
|
| Federal Management Financial Integrity Act (FMFIA) |
Division of Ethics and Management Operations, OMO |
|
| Federal Technology Transfer Act (FTTA) |
CDRH, Office of the Center Director, FDA |
|
| Federal-State Relations |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Fellowship Opportunities |
Office of the Center Director, CDRH |
|
| Fiber Optics |
Division of Physics, OSEL |
|
| Flow Cytometer-Premarket |
Division of Immunology and Hematology Devices, OIVD |
|
| Flow Cytometer-Scientific/Technical |
Division of Biology, OSEL |
|
| Fluid Mechanics |
Division of Solid and Fluid Mechanics, OSEL |
|
| Fluorescence Spectroscopy and Imaging |
Division of Physics, OSEL |
|
| Fluoroscopy - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch I, OSB |
|
| Fluoroscopy - Compliance |
Division of Enforcement B, OC |
|
| Fluoroscopy - OCER Contact |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Fluoroscopy - Scientific/Technical |
Division of Imaging and Applied Mathematics, OSEL |
|
| Focus Testing |
Division of Device User Programs and Systems Analysis, OCER |
|
| FOI (Freedom of Information) |
Division of Ethics and Management Operations, OMO |
|
| FOI-Reading Room |
Office of Management Programs, Division of Freedom of Information, FDA |
|
| Food and Drug Administration Modernization Act (FDAMA) |
CDRH, Office of the Director, FDA |
|
| Food Irradiation |
Center for Food Safety and Applied Nutrition, Division of Petition Control, FDA |
|
| Foreign Inspections |
Division of Risk Management, OC |
|
| Foreign Liaison |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
| FTTA (Federal Technology Transfer Act) |
Office of the Director, CDRH, OCD |
|
| G |
| GAO (General Accounting Office) |
Division of Planning, Analysis and Finance, OSM, OMO |
|
| Gastroenterology - Premarket |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Gastroenterology Devices |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| General Accounting Office (GAO) |
Division of Planning, Analysis and Finance, OSM, OMO |
|
| Genetics - Examination, Surgical and Related Accessories |
Division of Biology, OSEL |
|
| Genomics-Regulatory |
Office of the Director, OIVD |
|
| Genomics-Scientific/Technical |
Division of Biology, OSEL |
|
| Germicides (All Disinfectants Other Than LCS/HLD are Class I) |
Division of Postmarket Surveillance, OSB |
|
| Germicides (All Disinfectants Other Than LCS/HLD are Class I) |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Gloves - Examination, Surgical and Related Accessories - Premarket |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Gloves- Scientific/Technical |
Division of Chemistry and Materials Science, OSEL |
|
| Good Manufacturing Practices |
Division of Enforcement B, OC |
|
| H |
| Health Professional Organizations |
Division of Device User Programs and Systems Analysis, OCER |
|
| Hearing Aid- Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Hearing Aid- Compliance |
Division of Enforcement A, OC |
|
| Hearing Aids - Patient Labeling |
Division of Device User Programs and Systems Analysis, OCER |
|
| Hearing Aids - Premarket |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Heart Valves-Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch I, OSB |
|
| Heart Valves-Compliance |
Division of Enforcement B, OC |
|
| Heart Valves-Premarket |
Division of Cardiovascular Devices, ODE |
|
| Heaters |
Division of Physics, OSEL |
|
| Hematology Products - Processes |
Associate Director for Hematology, OIVD |
|
| Hemodialysis - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Hemodialysis - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Hemodialysis - Scientific/Technical |
Division of Solid and Fluid Mechanics, OSEL |
|
| Hemodialysis - User Problems |
Division of Device User Programs and Systems Analysis, OCER |
|
| High Voltage Lines |
Division of Physics, OSEL |
|
| Hip Replacement-Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Hip Replacement-Compliance |
Division of Enforcement B, OC |
|
| Hip Replacement-Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Home Use Devices-Adverse Events |
Division of Surveillance Systems, OSB |
|
| Home Use In-Vitro Devices - Labeling Issues |
Division of Device User Programs and Systems Analysis, OCER |
|
| Home Use In-Vitro Devices - Premarket |
Deputy Office Director, OIVD |
|
| Hospital Beds and Cribs - Compliance |
Division of Enforcement A, OC |
|
| Hospital Beds and Cribs-Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Hospital Beds and Cribs-Scientific/Technical |
Division of Chemistry and Materials Science, OSEL |
|
| Hospital Beds and Cribs-User Problems |
Division of Device User Programs and Systems Analysis, OCER |
|
| Host Respones-Effect of Materials and Implanted Devices |
Division of Biology, OSEL |
|
| Human Factors Engineering |
Division of Device User Programs and Systems Analysis, OCER |
|
| Human Research Protection for IVDs |
Division of Microbiology Devices, OIVD |
|
| Human Tissue |
Division of General, Restorative and Neurological Devices, ODE |
|
| Human Tissue Products |
Division of General, Restorative and Neurological Devices, ODE |
|
| Humanitarian Device Exemption (HDE) |
Program Operations Staff, ODE |
|
| Hyperbaric Chambers |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Hyperhthermia - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| I |
| Imaging Remote (Teleradiology)-Adverse Events |
Division of Postmarket Surveillance, OSB |
|
| Imaging Remote (Teleradiology)-Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Immunology - Products - Processes |
Associate Director for Immunology, OIVD |
|
| Immunology - Scientific/Technical |
Division of Biology, OSEL |
|
| Immunotoxicology |
Division of Biology, OSEL |
|
| Imports |
Division of Risk Management, OC |
|
| In Vitro Diagnostics - Compliance |
Deputy Director For Compliance, OIVD |
|
| In-Vitro Diagnostic Devices - Regulatory Guides and Labeling |
Office of In Vitro Diagnostic Device Evaluation and Safety , OIVD |
|
| In-Vitro Diagnostics Devices-Premarket |
Deputy Director For New Products Evaluation, OIVD |
|
| Incubators - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Incubators - Compliance |
Division of Enforcement A, OC |
|
| Incubators - Premarket |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Infant Monitors-Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Infant Monitors-Compliance |
Division of Enforcement A, OC |
|
| Infection Control - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch I, OSB |
|
| Infection Control - Education |
Division of Device User Programs and Systems Analysis, OCER |
|
| Infection Control - Mammography Quality Standards Act |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Infection Control - Premarket |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Infection Control - Scientific/Technical |
Division of Biology, OSEL |
|
| Infrared Diagnostics and Therapeutics |
Division of Physics, OSEL |
|
| Infrared Heating |
Division of General, Restorative and Neurological Devices, ODE |
|
| Infusion Pumps - Compliance |
Division of Enforcement A, OC |
|
| Infusion Pumps-Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Infusion Pumps-Premarket |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Inhalers |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Inspector General Inquiries |
Division of Planning, Analysis and Finance, OSM, OMO |
|
| Institutional Review Board (IRB) |
Division of Bioresearch Monitoring, OC |
|
| Institutional Review Board IRB |
Program Operations Staff, ODE |
|
| Insulin Pumps |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Insulin Pumps - Compliance |
Division of Enforcement A, OC |
|
| Integrity Program |
Division of Integrity, Committee and Conference Management, OSM |
|
| Integrity Program |
Division of Ethics and Management Operations, OMO |
|
| Interagency Agreements |
Office of the Director, CDRH, OCD |
|
| International Affairs |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
| Internet (CDRH) |
Division of Device User Programs and Systems Analysis, OCER |
|
| Internet Advertising |
Promotion and Advertising Policy Staff, OC |
|
| Interstitial Cystitis |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Intracerebral, Subcortical Stimulator (pain relief) |
Division of General, Restorative and Neurological Devices, ODE |
|
| Intranet (CDRH) |
Program Management Operations, OCER |
|
| Intraoclular Lens-Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Intraoclular Lens-Scientific/Technical |
Division of Physics, OSEL |
|
| Intraocular Lens-Premarket |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Intravenous Tubing-Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Investigational Device Exemption (IDE) |
Program Operations Staff, ODE |
|
| Iodine-123 |
Office of the Director, OCER |
|
| J |
| Joints- Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Joints-Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| L |
| Labeling - Compliance |
Office of the Director, OC |
|
| Labeling - Compliance |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
| Labeling - Development |
Division of Device User Programs and Systems Analysis, OCER |
|
| Labeling - In-Vitro Diagnostics |
Division of Enforcement A, OC |
|
| Labeling - Industry Assistance |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
| Labeling - Patient |
Division of Device User Programs and Systems Analysis, OCER |
|
| Labeling - Patient Labeling |
Division of Device User Programs and Systems Analysis, OCER |
|
| Laser - Bioeffects |
Division of Biology, OSEL |
|
| Laser - Compliance |
Division of Enforcement B, OC |
|
| Laser - Consumer Assistance |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
| Laser - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Laser - Safety and Standards |
Division of Physics, OSEL |
|
| Laser - Scientific/Technical (Lithotripsy) |
Division of Physics, OSEL |
|
| Laser - Tissue Interactions (Optical, Thermal, Biochemical) |
Division of Physics, OSEL |
|
| Laser YAG - Compliance |
Division of Enforcement A, OC |
|
| Laser YAG - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Lasers - Metrology |
Division of Physics, OSEL |
|
| LASIK-Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| LASIK-Compliance |
Division of Enforcement A, OC |
|
| LASIK-Premarket |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Latex - Allergy |
Division of Biology, OSEL |
|
| Latex - Chemistry |
Division of Chemistry and Materials Science, OSEL |
|
| Latex - Compliance |
Division of Enforcement A, OC |
|
| Latex - Industry Guidance |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
| Latex - Labeling |
Division of Enforcement A, OC |
|
| Latex-Scientific/Technical |
Division of Biology, OSEL |
|
| Learning Laboratory |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Library - Bioscience at White Oak |
White Oak Campus, FDA |
|
| Light Propagation/Diffusion |
Division of Physics, OSEL |
|
| Light Radiation (ultraviolet / sunlamp) - Compliance |
Division of Enforcement B, OC |
|
| Light Radiation (ultraviolet / sunlamp) - Eye |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Light Radiation (ultraviolet / sunlamp) - Skin |
Division of Biology, OSEL |
|
| Light Radiation - Compliance |
Division of Enforcement B, OC |
|
| Light Radiation - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Light Radiation - Scientific/Technical |
Division of Physics, OSEL |
|
301-796-2494 301-796-0234
|
|
|
|
| Linear Accelerators - Adverse Events |
Division of Postmarket Surveillance, OSB |
|
| Linear Accelerators - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Liposuction-Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Liposuction-Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Liquid Chemical Sterillants/High Level Disinfectants-Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch I, OSB |
|
| Liquid Chemical Sterillants/High Level Disinfectants-Premarket |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Lithotripter-Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| M |
| Magnetic Resonance Imaging (MRI)-Adverse Events |
Division of Postmarket Surveillance, OSB |
|
| Magnetic Resonance Imaging (MRI)-Compliance |
Division of Enforcement B, OC |
|
| Magnetic Resonance Imaging (MRI)-Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Magnetic Resonance Imaging (MRI)-Scientific/Technical |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Magnets |
Division of Enforcement B, OC |
|
| Male Sexual Dysfunction |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Mammography - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Mammography-Compliance |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Manufacturers and User Device Experience (MAUDE) |
Office of the Director, OSB |
|
| Manufacturers Assistance |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
240-276-3150
/ 1-800-638-2041
|
|
|
|
| Master Files |
Program Operations Staff, ODE |
|
| Materials |
Division of Chemistry and Materials Science, OSEL |
|
| Mechanical Durability |
Division of Solid and Fluid Mechanics, OSEL |
|
| Med Watch |
CDER |
|
| Med Watch |
CDER |
|
| Media |
Office of the Center Director, CDRH |
|
| Medical Device Fellowship Program |
Medical Device Fellowship Program, OCD |
|
| Medical Device Reporting (MDR) - Interpretation of Regulation |
Division of Surveillance Systems, OSB |
|
| Medical Device Reporting (MDR) - Interpretation of Regulation |
Reporting Systems Monitoring Branch - OSB |
|
| Medical Device Reporting (MDR) - Requirements for Reporting |
Reporting Systems Monitoring Branch - OSB |
|
| Medical Device Reporting (MDR) - Requirements for Reporting |
Reporting Systems Monitoring Branch - OSB |
|
| Medical Device Reporting MDR - General Program |
Office of the Director, OSB |
|
| Medical Device User Fee and Modernization Act (MDUFMA) |
Office of the Center Director, CDRH |
|
| Medical Imaging |
Division of Imaging and Applied Mathematics, OSEL, FDA |
|
| Medical Physics-Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Medical Physics-Scientific/Technical |
Division of Imaging and Applied Mathematics, OSEL, FDA |
|
| MedWatch |
CDER |
|
| MedWatch |
CDER |
|
| Memorandum of Understanding (MOU) |
Office of the Center Director, CDRH |
|
| Mercury Vapor Lamps |
Division of Enforcement B, OC |
|
| Metals-Chemistry and Properties |
Division of Chemistry and Materials Science, OSEL |
|
| Microbiology |
Division of Microbiology Devices, OIVD |
|
| Microwave Transmitters and Metrology |
Division of Physics, OSEL |
|
| Microwaves (Bioeffects) |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Molecuar Biology |
Division of Biology, OSEL |
|
| Molecular Genetics |
Office of In Vitro Diagnostic Device Evaluation and Safety , OIVD |
|
| Molecular Oncology and Diagnostics |
Associate Director for Immunology, OIVD |
|
| Monoclonal Antibodies |
Associate Director for Immunology, OIVD |
|
| Muscle Stimulator -Compliance |
Division of Enforcement B, OC |
|
| Muscle Stimulator-Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Muscle Stimulator-Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Mutual Recognition Agreement (MRA) |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
| N |
| N95 Respirators-Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| N95 Respirators-Premarket |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Nanotechnology |
Division of Chemistry and Materials Science, OSEL |
|
| Nanotechnology Particle Imaging and Characterization |
Division of Physics, OSEL |
|
| Nanotoxicology |
Division of Biology, OSEL |
|
| Nationwide Evaluation of X-ray Trends (NEXT) |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Naturally Occuring and Accelerator Produced Radioactive Material(NARM) |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Neonatal (In Vitro Testing) |
Deputy Office Director, OIVD |
|
| Nerve Stimulators - Compliance |
Division of Enforcement B, OC |
|
| Nerve Stimulators-Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Nerve Stimulators-Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Neurological Catheters-Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Neurological Catheters-Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Neurological Devices - Compliance |
Division of Enforcement B, OC |
|
| Neurological Devices-Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Neurological Devices-Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Neurological Embolization |
Division of General, Restorative and Neurological Devices, ODE |
|
| Nuclear Magnetic Resonance Imaging - Compliance |
Division of Enforcement I, OC |
|
| Nuclear Magnetic Resonance Imaging - Device Evaluation |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Nuclear Magnetic Resonance Imaging - Radiation Risk |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Nuclear Medicine - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch I, OSB |
|
| Nuclear Medicine - Medical Associations |
Office of the Director, OCER |
|
| Nuclear Medicine - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Nuclear Medicine - Radiation Risk |
Office of the Director, OCER |
|
| Nuclear Medicine - Scientific/Technical |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Nuclear Medicine - Therapy |
Division of Biology, OSEL |
|
| O |
| OB/GYN Devicers - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| OB/GYN Devices - Compliance |
Division of Enforcement A, OC |
|
| OB/GYN Devices -Adverse Events |
Division of Postmarket Surveillance, OSB |
|
| Obstetrics |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Occupational Health and Safety |
Division of Ethics and Management Operations, OMO |
|
| Office of Public Affairs Contact |
Office of the Director, CDRH, OCD |
|
| Office of Public Affairs Contact |
Print Media |
|
| Ombudsman |
CDRH, Office of the Center Director, FDA |
|
| Ophthalmic Devices - Compliance |
Division of Enforcement A, OC |
|
| Ophthalmic Devices-Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Ophthalmic Devices-Premarket |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Optical Biosensors |
Division of Physics, OSEL |
|
| Optical Diagnostics |
Division of Physics, OSEL |
|
| Optical Fabrication |
Division of Physics, OSEL |
|
| Optical Imaging-Scientific/Technical |
Division of Physics, OSEL |
|
| Optical Metrology |
Division of Physics, OSEL |
|
| Optical Physics and Microscopy |
Division of Physics, OSEL |
|
| Optical Radiation (Sunlamps, Suntan Booth) - Compliance |
Division of Enforcement B, OC |
|
| Optical Radiation (Sunlamps, Suntan Booth) - Scientific/Technical |
Division of Biology, OSEL |
|
| Optical Radiation (Sunlamps, Suntan Booth)-Premarket |
Division of General , Restorative and Neurological Devices,Orthopedic Spine, ODE |
|
| Optical Radiation Measurement |
Division of Physics, OSEL |
|
| Optical Spectroscopy |
Division of Physics, OSEL |
|
| Optical Therapeutics |
Division of Physics, OSEL |
|
| Orphan Devices |
Program Operations Staff, ODE |
|
| Orthopedics - Compliance |
Division of Enforcement B, OC |
|
| Orthopedics-Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Orthopedics-Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
240-276-3659
/ 240-276-3676
|
|
|
|
| Osteoporosis Testing |
Associate Director for Chemistry, OIVD |
|
| Over the Counter In Vitro Devices |
Deputy Office Director, OIVD |
|
| Oxygen Generators-Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Oxygen Generators-Premarket |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Ozone Generators |
Division of Enforcement A, OC |
|
| P |
| Pacemakers - Compliance |
Division of Enforcement B, OC |
|
| Pacemakers - Implant Letters |
Health Care Financing Administration, FDA |
|
| Pacemakers - Postmarket |
Division of Postmarket Surveillance, OSB |
|
| Pacemakers-Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Pain Relief Devices - Compliance |
Division of Enforcement B, OC |
|
| Pain Relief Devices-Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Pandemic Flu |
Office of the Director, OIVD |
|
| Panel Meetings |
Office of the Director, ODE |
|
| PAP Smear Preparation Devices and Readers |
Associate Director for Hematology, OIVD |
|
| Paperwork Reduction Act |
Division of Ethics and Management Operations, OMO |
|
| Parasitology |
Associate Director for Bacteriology, OIVD |
|
| Part 11 Electronic Records and Signatures |
Division of Enforcement B, OC |
|
| Patents |
Regulations Staff, OCER |
|
| Pathology - Compliance |
Division of Enforcement A, OC |
|
| Pathology-Premarket |
Division of Immunology and Hematology Devices, OIVD |
|
| Patient (lay) Use |
Division of Device User Programs and Systems Analysis, OCER |
|
| Patient Cables and Lead Wires-Adverse Events |
Division of Postmarket Surveillance, OSB |
|
| Patient Cables and Lead Wires-Compliance |
Division of Enforcement B, OC |
|
| Patient Labeling |
Division of Device User Programs and Systems Analysis, OCER |
|
| Patient Restraints |
Division of Enforcement A, OC |
|
| Pediatrics |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Performance Management |
Division of Planning, Analysis and Finance, OSM, OMO |
|
| Personalized Medicine |
Office of the Director, OIVD |
|
| Personnel - Civil Service |
Employee Resource Information Center (ERIC), FDA |
|
| Personnel - Commissioned Corps |
Division of Ethics and Management Operations, OMO |
|
| Petitions |
Regulations Staff, OCER |
|
| Pharmacogenomics |
Office of In Vitro Diagnostic Device Evaluation and Safety , OIVD |
|
| Physical Medicine Products - Compliance |
Division of Enforcement B, OC |
|
| Physical Medicine Products-Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Physical Medicine Products-Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Physical Therapy - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Physical Therapy - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Picture Archiving Communications System |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Picture Archiving Communications System - Device Evaluation |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Plastic Surgery-Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Plastic Surgery-Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Point of Care In Vitro Testing |
Office of the Director, OIVD |
|
| Polymers-Chemistry And Properties |
Division of Chemistry and Materials Science, OSEL |
|
| Positron Emission Tomography (PET) Scan - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch I, OSB |
|
| Positron Emission Tomography (PET) Scan - Compliance |
Division of Enforcement B, OC |
|
| Positron Emission Tomography (PET) Scan - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Positron Emission Tomography (PET) Scan - Scientific/Technical |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Positron Emission Transaxial Tomography ( PET Scan) - Compliance |
Division of Enforcement I, OC |
|
| Positron Emission Transaxial Tomography ( PET Scan) Clinical |
Office of the Director, OCER |
|
| Post Approval Studies |
Division of Postmarket Surveillance, OSB |
|
| Postmarket Issue Action Teams |
Issues Management Staff, OSB |
|
| Postmarket Studies |
Division of Postmarket Surveillance, OSB |
|
| Postmarket Surveillance Studies |
Issues Management Staff, OSB |
|
| Postmarket Transformation Team |
Office of the Center Director, CDRH |
|
| Power Lines -Scientific/Technical |
Division of Physics, OSEL |
|
301-796-2472
/ 301-796-0234
|
|
|
|
| Pre-IDE Submissions |
Program Operations Staff, ODE |
|
| Pregnancy Test Kits - Compliance |
Deputy Director For Compliance, OIVD |
|
| Pregnancy Test Kits-Premarket |
Associate Director for Chemistry, OIVD |
|
| Premarket Approval (PMA)-Adverse Events |
Division of Postmarket Surveillance, OSB |
|
| Premarket Approval (PMA)-Premarket |
Premarket Approval Staff, ODE |
|
| Premarket Notification (510(k)) |
Program Operations Staff, ODE |
|
| Press |
Office of the Center Director, CDRH |
|
| Process Management and Improvement |
Office of the Center Director, CDRH |
|
| Product Reliability |
Division of Electrical and Software, OSEL |
|
| Products Codes |
Program Operations Staff, ODE |
|
| Promotion Labeling/Advertising |
Promotion and Advertising Policy Staff, OC |
|
| Prostate Cancer |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Prosthetic Limb Devices-Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Prosthetic Limb Devices-Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Proteomics |
Office of the Director, OIVD |
|
| PSA Testing |
Division of Immunology and Hematology Devices, OIVD |
|
| Psoriasis Phototherapy (PUVA) |
Division of General, Restorative and Neurological Devices, ODE |
|
| Public Health Notifications |
Issues Management Staff, OSB |
|
| Publications and Brochures |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
240-276-3150
/ 1-800-638-2041
|
|
|
|
| Q |
| Qualitative Research |
Division of Device User Programs and Systems Analysis, OCER |
|
| Quality Assurance |
Office of the Director, OC |
|
| Quality Assurance (Diagnostic Radiology and Mammography) |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Quality Systems |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
| Quality/Risk Management |
Division of Electrical and Software, OSEL |
|
| Qualtiy Assurance - Technique Exposure Guides |
Division of Mammography Quality and Radiation Programs, OCER |
|
| R |
| Radiation Biology (Ionizing and Non-Ionizing Radiation) |
Division of Biology, OSEL |
|
| Radiation Emergency Planning and Response |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Radiation Metrology - Ionizing Radiation |
Division of Imaging and Applied Mathematics, OSEL, FDA |
|
| Radiation Metrology - Non-Ionizing Radiation |
Division of Physics, OSEL |
|
| Radiation Monitoring |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Radiation Safety Officer (CDRH) |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Radiation Therapy - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch I, OSB |
|
| Radiation Therapy - Compliance |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Radiation Therapy - Compliance |
Division of Biology, OSEL |
|
| Radiation Therapy - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Radiation Therapy - Scientific/Technical |
Division of Biology, OSEL |
|
| Radiation, Broadcast Station |
Environmental Protection Agency, FDA |
|
| Radio Frequency (RF) Heaters |
Division of Physics, OSEL |
|
301-796-2472
/ 301-796-0234
|
|
|
|
| Radio Frequency ID (RFID) |
Division of Physics, OSEL |
|
| Radio Frequency ID (RFID) - Compliance |
Division of Enforcement B, OC |
|
| Radio Frequency ID (RFID) - Scientific/Technical |
Division of Physics, OSEL |
|
| Radio Frequency Sealers - Scientific/Technical |
Division of Biology, OSEL |
|
| Radio Frequency Sealers - Scientific/Technical |
Division of Biology, OSEL |
|
| Radioactive Consumer Products ( Dishes, Jewelry, Watches) |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Radiology Clinical |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Radiology Imaging - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch I, OSB |
|
| Radiology Imaging - Compliance |
Division of Enforcement A, OC |
|
| Radiology Imaging - Premarket |
Division of Enforcement I, OC |
|
| Radiology Imaging - Premarket |
Office of Surveillance and Biometrics, OSB |
|
| Radiology Imaging - Premarket |
Division of Imaging and Applied Mathematics, OSEL, FDA |
|
| Radiology Imaging - Premarket |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Radiology Imaging - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Radiology Imaging - Scientific/Technical |
Division of Imaging and Applied Mathematics, OSEL, FDA |
|
| Radiopharmaceuticals |
Office of the Director, OCER |
|
| Recalls Notification - Compliance |
Division of Risk Management, OC |
|
| Recalls Notification - Patient Notification |
Division of Device User Programs and Systems Analysis, OCER |
|
| Reclassification - FR Notices |
Regulations Staff, OCER |
|
| Reclassification - Premarket |
Program Operations Staff, ODE |
|
| Registration and Listing |
Regulatory Policy and Systems Branch, OC |
|
| Regulations - Software |
Division of Electrical and Software, OSEL |
|
| Regulations and Policy |
CDRH, Office of the Center Director, FDA |
|
| Regulatory Guidance |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
240-276-3150
/ 1-800-638-2041
|
|
|
|
| Rehabilitation Devices |
Division of General, Restorative and Neurological Devices, ODE |
|
| Replacement Reagents |
Office of the Director, OIVD |
|
| Request for Information Regarding Classification 513(g) |
Program Operations Staff, ODE |
|
| Reuse of Single Use Devices |
Office of the Director, OC |
|
| Reverse Isolation Patient Chambers and Transport Units |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Risk Analysis and Management - User Error |
Division of Device User Programs and Systems Analysis, OCER |
|
| Risk Based Work Planning |
Division of Risk Management, OC |
|
| Risk Management |
Division of Electrical and Software, OSEL |
|
| S |
| Safe Medical Device Act (SMDA) |
Regulations Staff, OCER |
|
| Safety Alerts |
Issues Management Staff, OSB |
|
| Sharps Containers - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Sharps Containers - Compliance |
Division of Enforcement A, OC |
|
| Sharps Containers -Premarket |
Division of Enforcement A, OC |
|
| Sharps Containers -Premarket |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Silicone |
Division of General, Restorative and Neurological Devices, ODE |
|
| Silicone - Consumer Information |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
| Silicone Devices/Implants - Consumer Information |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
| Silicone Devices/Implants - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Silicone Devices/Implants - Scientific/Technical |
Division of Chemistry and Materials Science, OSEL |
|
| Single Photo Computed Tomography (SPECT) Scan - Adverse Events |
Division of Surveillance Systems, OSB |
|
| Single Photon Computed Tomography (SPECT) Scan - Compliance |
Division of Enforcement A, OC |
|
| Single Photon Computed Tomography (SPECT) Scan - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Smoke Detector |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Snoring Devices |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Snoring Devices (Jaw Positioning) |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Snoring Devices - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Snoring Devices - Premarket |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Software and Computerized Medical Devices - Compliance |
Division of Imaging and Applied Mathematics, OSEL, FDA |
|
| Software and Computerized Medical Devices - Compliance |
Regulations Staff, OCER |
|
| Software and Computerized Medical Devices - Compliance |
Division of Enforcement B, OC |
|
| Software and Computerized Medical Devices - Compliance |
Division of Enforcement B, OC |
|
| Software and Computerized Medical Devices - Compliance |
Division of Cardiovascular Devices, ODE |
|
| Software and Computerized Medical Devices - Compliance |
Division of Postmarket Surveillance, Product Evaluation Branch I, OSB |
|
| Software and Computerized Medical Devices - Scientific/Technical |
Division of Imaging and Applied Mathematics, OSEL, FDA |
|
| Software Reviews and Design Adequacy |
Division of Electrical and Software, OSEL |
|
| Solid Mechanics |
Division of Solid and Fluid Mechanics, OSEL |
|
| SPECT Scan |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| SPECT Scan |
Division of Enforcement I, OC |
|
| SPECT Scan |
Office of the Director, OCER |
|
| Spinal Cord Stimulator (For Pain) - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Spinal Cord Stimulator (For Pain) - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Spinal Cord Stimulator (For Pain) - Premarket |
Division of General , Restorative and Neurological Devices,Orthopedic Spine, ODE |
|
| Spinal Cord Stimulator (For Pain) - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Staff College |
Staff College, OCER |
|
| Standards |
Standards Management Staff, OSEL |
|
| State Medical Device and Radiological Health Activities |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Statistics/Statistical Analysis |
Division of Biostatistics, OSB |
|
| Stents - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch I, OSB |
|
| Stents - Compliance |
Division of Enforcement B, OC |
|
| Stents - Premarket (Coronary) |
Division of Cardiovascular Devices, ODE |
|
| Stents - Premarket (Neuro) |
Division of General , Restorative and Neurological Devices,Orthopedic Spine, ODE |
|
| Stents - Premarket (Peripheral) |
Division of Cardiovascular Devices, ODE |
|
| Sterilants, Liquid and Germicides |
Division of Enforcement A, OC |
|
| Sterilization |
Division of Enforcement I, OC |
|
| Sterilization |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Sterilization - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch I, OSB |
|
| Sterilization - Compliance |
Division of Enforcement A, OC |
|
| Sterilization - Premarket |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Sterilizers |
Division of Enforcement A, OC |
|
| Stimulator |
Division of General, Restorative and Neurological Devices, ODE |
|
| Stimulator - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Stimulator - Compliance |
Division of Enforcement B, OC |
|
| Stimulator - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Strategic Plan |
Office of the Center Director, CDRH |
|
| Student Programs |
Medical Device Fellowship Program, OCD |
|
| Submission Addresses |
Office of the Director, ODE |
|
| Sunglasses |
Division of Enforcement B, OC |
|
| Sunglasses |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
| Sunglasses - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Sunglasses - Compliance |
Division of Enforcement A, OC |
|
| Sunglasses - Consumer Assistance |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
| Suntanning Devices - Compliance |
Division of Enforcement B, OC |
|
| Suntanning Devices - Consumer Assistance |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
| Suntanning Devices - Effects |
Division of Biology, OSEL |
|
| Suntanning Devices - Skin |
Division of Biology, OSEL |
|
| Suntanning Devices - Skin |
Division of Device User Programs and Systems Analysis, OCER |
|
| Surface and Interfacial Interactions - Adhesion and Wetting |
Division of Chemistry and Materials Science, OSEL |
|
| Surgical |
Division of Enforcement I, OC |
|
| Surgical |
Division of General, Restorative and Neurological Devices, ODE |
|
| Surgical Devices - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Surgical Devices - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Surgical Drapes, Gowns and Masks - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Surgical Drapes, Gowns and Masks - Premarket |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Sutures |
Division of General, Restorative and Neurological Devices, ODE |
|
| Sutures - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Sutures - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Syringes - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Syringes - Compliance |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Syringes - Compliance |
Division of Enforcement A, OC |
|
240-276-0115
/ 240-276-3425
|
|
|
|
| Syringes - Compliance |
Division of Enforcement A, OC |
|
| Syringes - Device Evaluation |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Syringes - Premarket |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| System and Safety Engineering |
Division of Electrical and Software, OSEL |
|
| Systematic Technology Assessment for Medical Products ( STAMP) |
Issues Management Staff, OSB |
|
| T |
| Tampons - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch I, OSB |
|
| Tampons - Compliance |
Division of Enforcement A, OC |
|
| Tampons - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Tanning - Bioeffects |
Division of Biology, OSEL |
|
| Technology Transfer Agreements |
Office of the Center Director, CDRH |
|
| Teleconferences |
Division of Communication Media, OCER |
|
| Teleradiology |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Teleradiology - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Television |
Division of Enforcement B, OC |
|
| Television - Compliance |
Division of Enforcement B, OC |
|
| Television Production |
Division of Communication Media, OCER |
|
| Television Studio |
Division of Communication Media, OCER |
|
| Temporomandibular Joint (TMJ) |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Temporomandibular Joint (TMJ) |
Division of Enforcement A, OC |
|
| Temporomandibular Joint (TMJ) - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Temporomandibular Joint (TMJ) - Compliance |
Division of Enforcement A, OC |
|
| Temporomandibular Joint (TMJ) - Consumer Assistance |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
| Temporomandibular Joint (TMJ) - Premarket |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Test Kits |
Office of In Vitro Diagnostic Device Evaluation and Safety , OIVD |
|
| Thermograph |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Thermography - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Third Party Accreditation |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
| Third Party Reviews of 510(k)s |
Program Operations Staff, ODE |
|
| Time Reporting |
Division of Planning, Analysis and Finance, OSM, OMO |
|
| Tissue Engineered Medical Products (TEMPs) |
Division of Solid and Fluid Mechanics, OSEL |
|
| Toxic Shock Syndrome (TSS) - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch I, OSB |
|
| Toxic Shock Syndrome (TSS) - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Toxicology |
Division of Enforcement I, OC |
|
| Toxicology |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Toxicology |
Division of Biology, OSEL |
|
| Toxicology - Compliance |
Division of Enforcement A, OC |
|
| Toxicology - Premarket |
Associate Director for Toxicology, OIVD |
|
| Toxicology - Scientific/Technical |
Division of Biology, OSEL |
|
| Traction - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Traction - Premarket |
Division of General , Restorative and Neurological Devices,Orthopedic Spine, ODE |
|
| Trade Press |
CDRH, Office of the Center Director, FDA |
|
| Training |
Staff College, OCER |
|
| Transcutaneous Electrical Nerve Stimulators (TENS) - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Transcutaneous Elelectrical Nerve Stimulators (TENS) - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Transillumination - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch I, OSB |
|
| Transillumination - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Transillumination- Adverse Events |
Division of Postmarket Surveillance, OSB |
|
| Transillumination- Compliance |
Division of Enforcement B, OC |
|
| Transillumination- Compliance |
Division of Enforcement B, OC |
|
| Transillumination- Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| TSS (Toxic Shock Syndrome) |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Tumor Marker Assays |
Associate Director for Immunology, OIVD |
|
| U |
| Ultrasound Fetal Heart Beat Monitors- Compliance |
Division of Enforcement A, OC |
|
| Ultrasound Fetal Keepsake Videos-Compliance |
Division of Enforcement B, OC |
|
| Ultrasound-Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch I, OSB |
|
| Ultrasound-Compliance |
Division of Enforcement A, OC |
|
| Ultrasound-Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Ultrasound-Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Ultrasound-Scientific/Technical |
Division of Solid and Fluid Mechanics, OSEL |
|
301-796-2502
/ 301-796-0234
|
|
|
|
| Ultraviolet Radiation (UV) - Bioeffects and Tissue Damage |
Division of Biology, OSEL |
|
301-796-0234
/ 301-796-2494
|
|
|
|
| Ultraviolet Radiation (UV) - Compliance |
Division of Mammography Quality and Radiation Programs, OCER |
|
| Ultraviolet Radiation (UV) - Premarket |
Division of General, Restorative and Neurological Devices, ODE |
|
| Unique Device Identification (UDI) |
Patient Safety Staff, OSB |
|
| Urethral Bulking Agents and Stents - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Urinary Incontinence - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Urinary Incontinence - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Urology - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Urology - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Urology Devices - Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Urology Devices - Compliance |
Division of Enforcement A, OC |
|
| Urology Devices - Compliance Issues |
Division of Enforcement A, OC |
|
| Urology Devices - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Usability (Testing, Validation, User Error) |
Division of Device User Programs and Systems Analysis, OCER |
|
| Use error |
Division of Device User Programs and Systems Analysis, OCER |
|
| User Fees, CDRH |
Office of the Director, CDRH, OCD |
|
| User Fees, CDRH |
Division of Planning, Analysis and Finance, OSM, OMO |
|
| User Fees, ODE and OIVD |
Program Operations Staff, ODE |
|
| User Interface |
Division of Device User Programs and Systems Analysis, OCER |
|
| UV (Ultraviolet Radiation) - Bioeffects |
Division of Biology, OSEL |
|
| UV (Ultraviolet Radiation) - Eye |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| UV (Ultraviolet Radiation) - Skin |
Division of Biology, OSEL |
|
| UV (Ultraviolet Radiation) - State and Local Regulations |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
|
240-276-3150
/ 1-800-638-2041
|
|
|
|
| V |
| Vascular Catheter Lock Flush Solutions |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Ventilators - Premarket |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Ventilators- Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Ventilators- Compliance |
Division of Enforcement B, OC |
|
| Ventilators- Premarket |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Vertebroplasty - Premarket |
Division of General , Restorative and Neurological Devices,Orthopedic Spine, ODE |
|
| Vertebroplasty- Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Vertebroplasty- Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
|
| Vertebroplasty-Premarket |
Division of General , Restorative and Neurological Devices,Orthopedic Spine, ODE |
|
| Video Conferencing |
Employee Resource Information Center (ERIC), FDA |
|
| Video Display Terminals (VDT) |
Division of Enforcement B, OC |
|
| Videotape Products |
Division of Communication Media, OCER |
|
| Virology |
Associate Director for Virology, OIVD |
|
| W |
| Waived Tests for CLIA |
Associate Director for Chemistry, OIVD |
|
| Webcasting |
Division of Communication Media, OCER |
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| Website |
Division of Device User Programs and Systems Analysis, OCER |
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| Wireless Medical Devices |
Division of Physics, OSEL |
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| World Health Organization (WHO) |
Division of Small Manufacturers, International and Consumer Assistance, OCER |
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240-276-3150
/ 1-800-638-2041
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| Wound Dressing - Compliance |
Division of Enforcement A, OC |
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| Wound Dressings -Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch II, OSB |
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| Wound Dressings -Premarket |
Division of General, Restorative and Neurological Devices, ODE |
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| X |
| X-ray - Compliance |
Division of Enforcement B, OC |
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| X-ray - Equipment |
Division of Mammography Quality and Radiation Programs, OCER |
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| X-ray - Premarket |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
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| X-ray - Scientific/Technical |
Division of Biology, OSEL |
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| X-Ray-Adverse Events |
Division of Postmarket Surveillance, Product Evaluation Branch I, OSB |
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| Y |
| YAG Laser |
Division of Enforcement A, OC |
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| Yorick, The Bionic Skeleton |
Institute, Smithsonian Institute |
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