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Document NameOff/Div/BrFOD# DateLinks
(1) Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff ODE 1337 05/29/2001  
(2) Availability of Information Given to Advisory Committee Members in Connection with CDRH Open Public Panel Meetings; Draft Guidance for Industry and FDA Staff ODE 1341 07/18/2001  
(3) A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff ODE 1347 11/10/2005  
(4) Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA ODE 361 08/30/2002  
(5) Guidance for Industry and FDA Staff - Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices ODE 1216 09/25/2006  
(6) Draft Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents ODE 1557 07/19/2007  
(7) Guidance for Submitting Reclassification Petition ODE 609 01/01/1997  
(8) SMDA Changes - Premarket Notification; Regulatory Requirements for Medical Devices (510k) Manual Insert ODE 655 04/17/1992  
(9) #D95-2, Attachment A (Interagency Agreement between FDA & HCFA) ODE 2106 09/15/1995  
(10) #D95-2, Attachment B (Criteria for Categorization of Investigational Devices (HCFA) ODE 3106 09/15/1995  
(11) 510(k) Quality Review Program (blue book memo) ODE 344 03/29/1996  
(12) Distribution and Public Availability of PMA Summary of Safety and Effectiveness Data Packages ODE 563 10/10/1997  
(13) HCFA Reimbursement Categorization Determinations for FDA-approved IDEs ODE 4106 09/15/1995  
(14) ODE Executive Secretary Guidance Manual G87-3 ODE 1338 08/07/1987  
(15) Letter to Industry, Powered Wheelchair/Scooter or Accessory/Component Manufacturer from Susan Alpert, Ph.D.,M.D. ODE 883 05/26/1994  
(16) Preamendments Class III Strategy ODE 611 04/19/1994  
(17) Application of the Device Good Manufacturing Practice (GMP) Regulation to the Manufacture of Sterile Devices ODE 267 12/01/1983  
(18) Classified Convenience Kits ODE 789 04/30/1993  
(19) Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1) ODE 935 01/10/1997  
(20) Format for IDE Progress Reports ODE 311 06/01/1996  
(21) Guideline on General Principles of Process Validation ODE 425 05/01/1987  
(22) Guideline on Validation of the Limulus Amebocyte Lysate (LAL) Test as an End-Product Endotoxin Test ODE 427 12/01/1987  
(23) Indications for Use Statement ODE 879 01/02/1996  
(24) Industry Representatives on Scientific Panel ODE 329 03/27/1987  
(25) Guidance for Industry; General/Specific Intended Use; Final ODE 499 11/04/1998  
(26) Frequently Asked Questions on the New 510(k) Paradigm; Final ODE 2230 10/22/1998  
(27) Convenience Kits Interim Regulatory Guidance ODE 562 05/20/1997  
(28) Guidance to Industry Supplements to Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review; Final ODE 380 05/20/1998  
(29) Medical Devices Containing Materials Derived from Animal Sources (Except In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry; Final ODE 2206 11/16/1998  
(30) A New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications ODE 905 03/20/1998  
(31) Guidance on Amended Procedures for Advisory Panel Meetings; Final ODE 413 07/22/2000  
(32) Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997 ODE 1135 08/09/2000  
(33) A Suggested Approach to Resolving Least Burdensome Issues ODE 1188 09/11/2000  
(34) Guidance on the Use of Standards in Substantial Equivalence Determinations; Final ODE 1131 03/12/2000  
(35) Guidance on IDE Policies and Procedures; Final ODE 882 01/20/1998  
(36) Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies - for Use by CDRH and Industry; Final ODE 322 02/19/1998  
(37) 30-Day Notices and 135-day PMA Supplements for Manufacturing Method or Process Changes, Guidance for Industry and CDRH (Docket 98D-0080); Final ODE 795 02/19/1998  
(38) New section 513(f)(2) - Evaluation of Automatic Class III Designation: Guidance for Industry and CDRH Staff; Final ODE 199 02/19/1998  
(39) Procedures for Class II Device Exemptions from Premarket Notification Guidance for Industry and CDRH Staff; Final ODE 159 02/19/1998  
(40) Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance ODE 198 04/01/1996 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080268.pdf]   
(41) Limulus Amebocute Lysate; Reduction of Samples for Testing ODE 178 10/23/1987 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM081920.pdf]   
(42) Master Files Part III; Guidance on Scientific and Technical Information ODE 338 06/01/1987  
(43) Points to Consider in the Characterization of Cell Lines Used to Produce Biological Products ODE 269 06/01/1984  
(44) Preamendment Class III Devices ODE 584 03/11/1992  
(45) Premarket Notification [510(k)] Status Request Form ODE 858 03/07/1994  
(46) Questions and Answers for the FDA Reviewer Guidance: Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities ODE 1198 09/03/1996 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080257.pdf]   
(47) Shelf Life of Medical Devices ODE 415 04/01/1991  
(48) Substantial Equivalence (SE) Decision Making Documentation ATTACHED: 'SE' Decision Making Process (Detailed) i.e. the decision making tree ODE 390 01/01/1990  
(49) Suggested Content for Original IDE Application Cover Letter ODE 797 02/27/1996  
(50) Threshold Assessment of the Impact of Requirements for Submission of PMAs for 31 Medical Devices Marketed Prior to May 28, 1976 ODE 352 01/01/1990  
(51) Memorandum of Understanding Regarding Patient Labeling Review (Blue Book Memo #G96-3) ODE 806 08/09/1996  
(52) Continued Access to Investigational Devices During PMA Preparation and Review (Blue Book Memo) (D96-1) ODE 872 07/15/1996  
(53) 510(k) Additional Information Procedures #K93-1 (blue book memo) ODE 886 07/23/1993  
(54) 510(k) Refuse to Accept Procedures #K94-1 (blue book memo) ODE 401 05/20/1994  
(55) 510(k) Sign-Off Procedures #K94-2 (blue book memo) ODE 308 06/03/1994  
(56) Cover Letter: 510(k) Requirements During Firm-Initiated Recalls; Attachment A: Guidance on Recall and Premarket Notification Review Procedures During Firm-Initiated Recalls of Legally Marketed Devices (blue book memo #K95-1) ODE 406 11/21/1995  
(57) Guidance on the Center for Devices and Radiological Health's Premarket Notification Review Program #K86-3 (blue book memo) ODE 289 06/30/1986  
(58) Premarket Notification - Consistency of Reviews #K89-1 (blue Book memo) ODE 339 02/28/1989  
(59) Consolidated Review of Submissions for Diagnostic Ultrasound Equipment, Accessories and Related Measurement Devices #G90-2 (blue book memo) ODE 30 10/19/1990  
(60) Consolidated Review of Submissions for Lasers and Accessories #G90-1 (blue book memo) ODE 31 10/19/1990  
(61) Device Labeling Guidance #G91-1 (blue book memo) ODE 414 03/08/1991  
(62) Review of Laser Submissions #G88-1 (blue book memo) ODE 330 04/15/1988  
(63) Toxicology Risk Assessment Committee #G89-1 (blue book memo) ODE 363 08/09/1989  
(64) Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (Replaces #G87-1 #8294) (blue book memo) ODE 164 05/01/1995  
(65) Goals and Initiatives for the IDE Program #D95-1 (blue book memo) ODE 405 07/12/1995  
(66) IDE Refuse to Accept Procedures #D94-1 (blue book memo) ODE 410 05/20/1994  
(67) Implementation of the FDA/HCFA Interagency Agreement Regarding Reimbursement Categorization of Investigational Devices, Att. A Interagency Agreement, Att. B Criteria for Catergorization of Investigational Devices, & Att. C -List #D95-2 (blue book memo) ODE 106 09/15/1995  
(68) Review of IDEs for Feasibility Studies #D89-1 (blue book memo) ODE 362 05/17/1989  
(69) Assignment of Review Documents #I90-2 (blue book memo) ODE 366 08/24/1990  
(70) Document Review Processing #I91-1 (blue book memo) ODE 446 02/12/1992  
(71) Integrity of Data and Information Submitted to ODE #I91-2 (blue book memo) ODE 447 05/29/1991  
(72) Meetings with the Regulated Industry #I89-3 (blue book Memo) ODE 367 11/20/1989  
(73) Nondisclosure of Financially Sensitive Information #I92-1 (blue book memo) ODE 587 03/05/1992  
(74) Policy Development and Review Procedures #I90-1 (blue book memo) ODE 368 02/15/1990  
(75) Telephone Communications Between ODE Staff and Manufacturers #I93-1 (blue book memo) ODE 360 01/29/1993  
(76) Panel Report and Recommendations on PMA Approvals #P86-5 (blue book memo) ODE 306 04/18/1986  
(77) Panel Review of Premarket Approval Applications #P91-2 (blue book memo) ODE 444 05/03/1991  
(78) PMA Compliance Program #P91-3 (blue book memo) ODE 445 05/03/1991  
(79) Premarket Approval Application (PMA) Closure #P94-2 (blue book memo) ODE 403 07/08/1994  
(80) Guidance for Off-the-Shelf Software Use in Medical Devices; Final ODE 585 09/09/1999  
(81) Kit Certification for 510(k)s ODE 562 07/01/1997  
(82) Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff ODE 310 02/28/2001  
(83) Center for Devices and Radiological Health's Investigational Device Exemption (IDE) Refuse to Accept Policy ODE 4859 06/30/1993  
(84) Center for Devices and Radiological Health's Premarket Notification [510(k)] Refuse to Accept Policy - (updated Checklist 3/14/1995) ODE 3859 06/30/1993  
(85) Suggested Format for Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions of FDAMA ODE 1195 11/02/2000  
(86) Deciding When To Submit a 510(k) for a Change to an Existing Wireless Telemetry Medical Device; Final Guidance for FDA Reviewers and Industry ODE 1073 11/30/2000  
(87) The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles: Final Guidance for FDA and Industry ODE 1332 10/04/2002  
(88) Determination of Intended Use for 510(k) Devices; Guidance for CDRH Staff ODE 857 12/03/2002  
(89) Pediatric Expertise for Advisory Panels; Guidance for Industry and FDA Staff ODE 1208 06/03/2003  
(90) Premarket Approval Application Modular Review - Guidance for Industry and FDA Staff ODE 835 11/03/2003  
(91) Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' - Draft Guidance for Industry and Food and Drug Administration Staff ODE 1811 04/23/2013  
(92) Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use ODE 1735 04/14/2011  
(93) Draft Guidance for Industry and Food and Drug Administration Staff - The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Low Glucose Suspend (LGS) Device Systems ODE 1759 06/22/2011  
(94) Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design ODE 1757 06/22/2011  
(95) Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems ODE 1728 07/26/2011  
(96) Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use ODE 1701 07/20/2011  
(97) Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: External Pacemaker Pulse Generator ODE 1769 10/17/2011 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm275701.htm]   
(98) Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities ODE 1582 04/25/2011  
(99) Draft Guidance for Industry and FDA Staff - Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling CBER
ODE
1644 05/02/2011  
(100) Draft Guidance for Industry and FDA Staff: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile CBER
ODE
1615 12/12/2008  
(101) Draft Guidance for Industry and FDA Staff - Functional Indications for Implantable Cardioverter Defibrillators ODE
OC
1304 10/06/2005  
(102) Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software ODE
OC
1553 01/14/2005  
(103) Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use ODE/DAGID 1734 02/07/2011  
(104) Draft Guideline for Industry and Food and Drug Administration Staff - Class II Special Controls Guideline: Temporary Mandibular Condyle Reconstruction Plate ODE/DAGID 1799 02/07/2013  
(105) Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA ODE/DAGID 1178 07/17/2002  
(106) Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA ODE/DAGID 1203 04/22/2003  
(107) Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities ODE/DAGID 1833 09/19/1995  
(108) Dental Impression Materials - Premarket Notification; Final ODE/DAGID 2203 08/17/1998 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073959.htm]   
(109) OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits; Final ODE/DAGID 2205 08/17/1998  
(110) Dental Cements - Premarket Notification; Final ODE/DAGID 2204 08/18/1998  
(111) Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme; Draft ODE/DAGID 1156 02/08/2000  
(112) Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities ODE/DAGID 833 03/01/1993 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM081341.pdf]   
(113) Guidance on the Content of Premarket Notification [510(k)] Submissions for Protective Restraints ODE/DAGID 993 12/01/1995  
(114) Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA ODE/DAGID/ARDB 1126 10/05/2001  
(115) Class II Special Control Guidance Document for Acute Upper Airway Obstruction Devices; Final ODE/DAGID/ARDB 1138 07/03/2000  
(116) Draft 510(K) Submission Requirements for Peak Flow Meters ODE/DAGID/ARDB 999 01/13/1994  
(117) Draft Emergency Resuscitator Guidance ODE/DAGID/ARDB 985 04/14/1993 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM081316.pdf]   
(118) Draft Reviewer Guidance for Ventilators ODE/DAGID/ARDB 500 07/01/1995 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080607.pdf]   
(119) Draft Reviewer Guidance on Face Masks and Shield for CPR ODE/DAGID/ARDB 996 03/16/1994 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM081256.pdf]   
(120) Excerpts Related to EMI from November 1993 Anesthesiology and Respiratory Devices Branch (includes EMI standard) ODE/DAGID/ARDB 638 11/01/1993  
(121) General Guidance Document: Non-Invasive Pulse Oximeter ODE/DAGID/ARDB 997 09/07/1992 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM081352.pdf]   
(122) Guidance for Oxygen Conserving Device 510(k) Review 73 BZD 868.5905 Non-continuous Ventilator Class II ODE/DAGID/ARDB 583 02/01/1989 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM081444.pdf]   
(123) Guidance for Peak Flow Meters for Over-the-Counter Sale ODE/DAGID/ARDB 998 06/23/1992 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM081354.pdf]   
(124) Heated Humidifier Review Guidance ODE/DAGID/ARDB 780 08/30/1991  
(125) Review Guidance for Oxygen Generators and Oxygen Equipment ODE/DAGID/ARDB 986    
(126) Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer; Final ODE/DAGID/ARDB 1157 01/24/2000  
(127) Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators ODE/DAGID/ARDB 784 10/01/1993  
(128) Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff ODE/DAGID/ARDB 1605 03/04/2013  
(129) Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCo2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA ODE/DAGID/ARDB 1335 12/13/2002  
(130) Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA ODE/DAGID/DEDB 1378 11/12/2002  
(131) Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff ODE/DAGID/DEDB 1389 05/12/2004  
(132) Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff ODE/DAGID/DEDB 642 10/26/2005  
(133) Guidance for Industry and FDA Staff - Class II Special Controls Document: Oral Rinse to Reduce the Adhesion of Dental Plaque ODE/DAGID/DEDB 1559 09/20/2005  
(134) Guidance Document on Dental Handpieces ODE/DAGID/DEDB 556 07/01/1995  
(135) Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Noble Metal Alloys ODE/DAGID/DEDB 1415 08/23/2004  
(136) Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Base Metal Alloys ODE/DAGID/DEDB 1416 08/23/2004  
(137) Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices - Guidance for Industry and FDA Staff ODE/DAGID/DEDB 1393 12/02/2003  
(138) Dental Bone Grafting Material Devices - Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff ODE/DAGID/DEDB 1512 04/28/2005  
(139) Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy - Guidance for Industry and FDA Staff ODE/DAGID/DEDB 1192 07/28/2009  
(140) Guidance for Industry and FDA Staff: Dental Handpieces - Premarket Notification [510(k)] Submissions ODE/DAGID/DEDB 556 05/02/2007  
(141) Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Remote Medication Management System ODE/DAGID/GHDB 1621 10/19/2007  
(142) Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes ODE/DAGID/GHDB 821 04/01/1993  
(143) Guidance on 510(k) Submissions for Implanted Infusion Ports ODE/DAGID/GHDB 392 10/01/1990  
(144) Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters ODE/DAGID/GHDB 824 03/16/1995 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080766.pdf]   
(145) Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers ODE/DAGID/GHDB 822 03/01/1993  
(146) Guidance on the Content of Premarket Notification [510(k)] Submissions for External Infusion Pumps ODE/DAGID/GHDB 823 03/01/1993  
(147) Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic Single Lumen Needles ODE/DAGID/GHDB 450 04/01/1993  
(148) Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA ODE/DAGID/GHDB 1326 03/12/2001  
(149) Guidance for Industry and FDA Review Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)] ODE/DAGID/GHDB 1189 07/11/2008  
(150) Neonatal and Neonatal Transport Incubators - Premarket Notifications; Final ODE/DAGID/GHDB 2201 09/18/1998  
(151) Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA Staff ODE/DAGID/GHDB 934 08/09/2005  
(152) Class II Special Controls Guidance document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information - Guidance for Industry and FDA Staff ODE/DAGID/GHDB 1541 12/10/2004  
(153) Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions ODE/DAGID/GHDB 1694 04/23/2010 [http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm209337.pdf]   
(154) Premarket Approval Applications (PMA) for Sharps Needle Destruction Devices; Final Guidance for Industry and FDA ODE/DAGID/INCB 891 03/02/2001  
(155) Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities ODE/DAGID/INCB 881 08/01/1993  
(156) Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes ODE/DAGID/INCB 888 08/01/1993 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM081305.pdf]   
(157) Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers ODE/DAGID/INCB 895 10/01/1993  
(158) Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA ODE/DAGID/INCB 1419 08/30/2002  
(159) Premarket Approval Applications (PMA) for Absorbable Powder for Lubricating a Surgeon’s Glove - Guidance for Industry and FDA Staff ODE/DAGID/INCB 1230 04/13/2004  
(160) Surgical Masks - Premarket Notification [510(k)] Submissions; Guidance for Industry and FDA ODE/DAGID/INCB 94 03/05/2004  
(161) Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff ODE/DAGID/INCB 1420 12/19/2003  
(162) Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies ODE/DAGID/INCB 1626 07/03/2007  
(163) Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA ODE/DAGID/INCB 1388 03/07/2002  
(164) Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors; Guidance for the Medical Device Industry and FDA Review Staff ODE/DAGID/INCB 1252 02/07/2002  
(165) Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products; Final ODE/DAGID/INCB 944 01/13/1999  
(166) Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants and High Level Disinfectants; Final ODE/DAGID/INCB 397 01/03/2000  
(167) Testing for Sensitizing Chemicals in Natural Rubber Latex Medical Devices (Addendum to 944) ODE/DAGID/INCB 1944 07/28/1997 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080210.pdf]   
(168) CDRH Regulatory Guidance for Washers and Washer-Disinfectors Intended for use in Processing Reusable Medical Devices ODE/DAGID/INCB 4 06/02/1998  
(169) Balloon Valvuloplasty Guidance For The Submission Of an IDE Application and a PMA Application ODE/DCD 370 01/01/1989  
(170) Battery Guidance ODE/DCD 873 01/01/1994  
(171) Policy for Expiration Dating (DCRND RB92-G) ODE/DCD 137 10/30/1992 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM081351.pdf]   
(172) Electrocardiograph (ECG) Electrode ODE/DCD/CEMB 25 02/11/1997 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080226.pdf]   
(173) Electrocardiograph (ECG) Lead Switching Adapter ODE/DCD/CEMB 26 02/11/1997 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080227.pdf]   
(174) Electrocardiograph (ECG) Surface Electrode Tester ODE/DCD/CEMB 27 02/11/1997 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080228.pdf]   
(175) Non-Invasive Blood Pressure (NIBP) Monitor Guidance ODE/DCD/CEMB 123 03/10/1997  
(176) Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance Version 1; Final ODE/DCD/CEMB 2239 11/19/1998  
(177) Recommended Clinical Study Design for Ventricular Tachycardia Ablation ODE/DCD/CEMB 2244 05/07/1999  
(178) Clinical Study Designs for Percutaneous Catheter Ablation for Treatment of Atrial Fibrillation - Guidance for Industry and FDA Staff ODE/DCD/CEMB 1229 01/09/2004  
(179) Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm ODE/DCD/CEMB 1363 10/28/2003 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM072673.pdf]   
(180) Coronary and Peripheral Arterial Diagnostic Catheters - Guidance for Industry and FDA Staff ODE/DCD/CEMB 1228 07/15/2003  
(181) Investigational Device Exemption (IDE) Study Enrollment for Cardiac Ablation of Typical Atrial Flutter; Final Guidance for Industry and FDA Reviewers ODE/DCD/CEMB 1199 11/08/2000  
(182) Cardiac Ablation Catheters Generic Arrhythmia Indications for Use; Guidance for Industry ODE/DCD/CEMB 1382 07/01/2002  
(183) Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Electrocardiograph Electrodes ODE/DCD/CEMB 1597 07/21/2011 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071256.htm]   
(184) Guidance for Industry and FDA Staff: Clinical Study Designs for Catheter Ablation Devices for Treatment of Atrial Flutter ODE/DCD/CEMB 1678 08/05/2008  
(185) Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff ODE/DCD/CSPB 1361 11/13/2000  
(186) Guidance for Annuloplasty Rings 510(k) Submissions; Final Guidance for Industry and FDA Staff ODE/DCD/CSPB 1358 01/31/2001  
(187) Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions; Final Guidance for Industry and FDA ODE/DCD/CSPB 1622 11/29/2000  
(188) Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions; Final Guidance for Industry and FDA ODE/DCD/CSPB 1632 11/29/2000  
(189) Draft Guidance for Industry and FDA Staff: Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications ODE/DCD/CSPB 1607 01/20/2010 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm193096.htm]   
(190) Coronary and Cerebrovascular Guidewire Guidance ODE/DCD/ICDB 964 01/01/1995  
(191) Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters ODE/DCD/ICDB 1608 09/08/2010 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm225145.htm]   
(192) Implantable Pacemaker Testing Guidance ODE/DCD/PDLB 383 01/12/1990  
(193) Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm); Final ODE/DCD/PDLB 2233 11/05/1998  
(194) Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement); Final ODE/DCD/PDLB 2232 11/05/1998  
(195) 1-Consolidated Annual Report for a Device Product Line (1-CARD); Pilot for Preparation of Annual Reports for Pacemaker Premarket Approval Applications ODE/DCD/PDLB 1167 07/06/2000  
(196) Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions ODE/DCD/PDLB 372 11/01/2000  
(197) Guidance Document for Vascular Prostheses 510(k) Submissions ODE/DCD/PVDB 1357 11/01/2000  
(198) Carotid Stent - Suggestions for Content of Submissions to the Food and Drug Administration in Support of Investigational Devices Exemption (IDE) Applications ODE/DCD/PVDB 974 10/26/1996  
(199) Guidance for Cardiovascular Intravascular Filter 510(k) Submissions; Final ODE/DCD/PVDB 24 11/26/1999  
(200) Implantable Intra-Aneurysm Pressure Measurement System - Class II Special Controls Guidance Document ODE/DCD/PVDB 1589 02/15/2006  
(201) Guidance for Industry and FDA Staff - Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems ODE/DCD/PVDB
ODE/DCD/ICDB
1545 04/18/2010  
(202) Guidance for Industry and FDA Staff: Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions ODE/DCD/PVDB
ODE/DCD/ICDB
1658 02/15/2008  
(203) Draft Guidance for Industry and Food and Drug Administration Staff - Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications ODE/DGRND 1784 07/27/2012  
(204) Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Absorbable Hemostatic Device ODE/DGRND 1558 10/31/2006  
(205) Guidance for Industry and FDA Staff - Pre-Clinical and Clinical Studies for Neurothrombectomy Devices ODE/DGRND/GSDB 1586 06/18/2007  
(206) Guidance Document for Surgical Lamp 510(k)s; Final ODE/DGRND/GSDB 1244 07/13/1998  
(207) Guidelines for Reviewing Premarket Notifications that Claim Substantial Equivalence to Evoked Response Stimulators ODE/DGRND/GSDB 593 02/01/1997  
(208) Guidance for the Preparation of a Premarket Notification for Extended Laparoscopy Devices ODE/DGRND/GSDB 667 08/30/1994  
(209) Guidance on the Content and Organization of a Premarket Notification for a Medical Laser ODE/DGRND/GSDB 386 06/01/1995  
(210) Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Electromyograph Needle Electrodes ODE/DGRND/GSDB 325 07/26/1995  
(211) Guidance Document for Powered Suction Pump 510(k)s ODE/DGRND/GSDB 2207 09/30/1998  
(212) Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions ODE/DGRND/INCB 1320 10/04/2007  
(213) Guidance for Industry and FDA Staff - Non-clinical Information for Femoral Stem Prostheses ODE/DGRND/ORDB   09/17/2007  
(214) Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device ODE/DGRND/ORDB 1540 06/12/2007  
(215) Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis ODE/DGRND/ORDB 1328 04/30/2002  
(216) 510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants ODE/DGRND/ORDB 47 02/20/1997  
(217) Guidance Document for Testing Biodegradable Polymer Implant Devices ODE/DGRND/ORDB 914 04/20/1996  
(218) Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant Components ODE/DGRND/ORDB 916 05/01/1995  
(219) Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone Or Bone Cement ODE/DGRND/ORDB 827 04/28/1994  
(220) Guidance Document For The Preparation of Premarket NotificationFor Ceramic Ball Hip Systems ODE/DGRND/ORDB 355 01/10/1995  
(221) Reviewers Guidance Checklist for Intramedullary Rods ODE/DGRND/ORDB 956 02/21/1997  
(222) Reviewers Guidance Checklist for Orthopedic External Fixation Devices ODE/DGRND/ORDB 829 02/21/1997  
(223) Guidance Document for the Preparation of IDE and PMA Applications for Intra-Articular Prothetic Knee Ligament Devices ODE/DGRND/ORDB 233 02/18/1993  
(224) Guidance Document for the Preparation of IDEs for Spinal Systems ODE/DGRND/ORDB 2250 01/13/2000  
(225) Guidance Document For Testing Bone Anchor Devices ODE/DGRND/ORDB 915 04/20/1996  
(226) ORDB 510(k) Sterility Review Guidance ODE/DGRND/ORDB 659 07/03/1997  
(227) Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA ODE/DGRND/ORDB 668 07/17/2002  
(228) Spinal System 510(k)s - Guidance for Industry and FDA Staff ODE/DGRND/ORDB 636 05/03/2004  
(229) Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis ODE/DGRND/ORDB 1193 10/31/2000  
(230) Guidance for Industry and FDA Staff: Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs ODE/DGRND/ORDB 1637 04/11/2008  
(231) Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA ODE/DGRND/ORDB 1418 01/16/2003  
(232) Clinical Data Presentations for Orthopedic Device Applications - Guidance for Industry and FDA Staff ODE/DGRND/ORDB 1542 12/02/2004  
(233) Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT) ODE/DGRND/PRSB 1702 11/10/2010 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm233275.htm]   
(234) Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin ODE/DGRND/PRSB 1683 11/10/2010 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm233027.htm]   
(235) Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Wound Dressing with Poly(diallyl dimethyl ammonium chloride) (pDADMAC) Additive ODE/DGRND/PRSB 1684 10/16/2009 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm186571.htm]   
(236) Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Expander ODE/DGRND/PRSB 1628 12/22/2008  
(237) Low Energy Ultrasound Wound Cleaner: Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff ODE/DGRND/PRSB 1302 11/07/2005  
(238) Guidance Document for Dura Substitute Devices; Final Guidance for Industry ODE/DGRND/PRSB 1152 11/09/2000  
(239) Class II Special Controls Guidance Document: Human Dura Mater; Guidance for Industry and FDA Staff ODE/DGRND/PRSB 54 12/18/2003  
(240) Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA ODE/DGRND/PRSB 1387 06/03/2003  
(241) Saline, Silicone Gel, and Alternative Breast Implants - Draft Guidance for Industry and FDA Staff ODE/DGRND/PRSB 1239 01/13/2004  
(242) Guidance for Testing MR Interaction with Aneurysm Clips ODE/DGRND/PRSB 958 05/22/1996  
(243) Guidance for Content of Premarket Notifications for Esophageal and Tracheal Prostheses; Final ODE/DGRND/PRSB 6 04/28/1998  
(244) Guidance for Dermabrasion Devices; Final ODE/DGRND/PRSB 2248 03/02/1999  
(245) Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; Final ODE/DGRND/PRSB 2247 03/02/1999  
(246) Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Guidance for Industry ODE/DGRND/PRSB 1356 06/18/2002  
(247) Guidance for Industry and FDA Staff - Saline, Silicone Gel, and Alternative Breast Implants ODE/DGRND/PRSB 1239 11/17/2006  
(248) Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology ODE/DGRND/PRSB 1629 08/03/2007  
(249) Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin ODE/DGRND/PRSB 1630 05/30/2008  
(250) Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA ODE/DGRND/REDB 855 06/02/2003  
(251) Guidance Document for Powered Muscle Stimulator 510(k)s; Final ODE/DGRND/REDB 2246 06/09/1999  
(252) Guidance Document for the Preparation of Notification (510(k)) Applications for Therapeutic Massagers and Vibrators ODE/DGRND/REDB 818 07/26/1995  
(253) Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Communications Systems (Powered and Non-Powered) and Powered Environmental Control Systems ODE/DGRND/REDB 762 07/26/1995  
(254) Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Exercise Equipment ODE/DGRND/REDB 326 07/26/1995  
(255) Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices ODE/DGRND/REDB 828 07/26/1995  
(256) Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Immersion Hydrobaths ODE/DGRND/REDB 729 07/26/1995  
(257) Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Powered Tables and Multifunctional Physical Therapy Tables ODE/DGRND/REDB 735 07/26/1995  
(258) Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Submerged (Underwater) Exercise Equipment ODE/DGRND/REDB 307 07/26/1995  
(259) Guidance Document for the Preparation of Premarket Notification [510k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles ODE/DGRND/REDB 346 07/26/1995  
(260) Guidance for Studies for Pain Therapy Devices - General Consideration in the Design of Clinical Studies for Pain-Alleviating Devices ODE/DGRND/REDB 640 05/12/1988  
(261) Clinical Trial Considerations: Vertebral Augmentation Devices to Treat Spinal Insufficiency Fractures - Guidance for Industry and FDA Staff ODE/DGRND/REDB
ODE/DGRND/ORDB
1543 10/24/2004  
(262) Guidance for Industry and Food and Drug Administration Staff - Contact Lens Care Products Labeling ODE/DOED 1725 08/15/2010  
(263) Guidance for Industry; Noise Claims in Hearing Aid Labeling; Final ODE/DOED 2210 10/21/1998  
(264) Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief ODE/DOED 1573 04/05/2010 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm199265.htm]   
(265) Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Electroconductive Media ODE/DOED 1571 04/05/2010 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm199256.htm]   
(266) Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Cutaneous Electrode ODE/DOED 1572 04/05/2010 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm199247.htm]   
(267) Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator for Muscle Conditioning ODE/DOED 1579 04/05/2010 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm199220.htm]   
(268) Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator for Aesthetic Purposes ODE/DOED 1575 04/05/2010 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm199067.htm]   
(269) Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator for Rehabilitation ODE/DOED 1577 04/05/2010 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm198793.htm]   
(270) Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator with Limited Output for Aesthetic Purposes ODE/DOED 1576 04/05/2010 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm199092.htm]   
(271) Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Rehabilitation ODE/DOED 1578 04/05/2010 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm198953.htm]   
(272) Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Muscle Conditioning ODE/DOED 1580 04/05/2010 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm198726.htm]   
(273) Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use ODE/DOED 1670 04/05/2010 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm198645.htm]   
(274) Discussion Points for Expansion of the 'Checklist of Information Usually Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers' Draft Document ODE/DOED/DSDB 7093 09/05/1997  
(275) Third Party Review Guidance for Phacofragmentation System Device Premarket Notification (510(k)) ODE/DOED/DSDB 2197 01/31/1997 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080231.pdf]   
(276) Third Party Review Guidance for Vitreous Aspiration and Cutting Device Premarket Notification (510(k)) ODE/DOED/DSDB 2196 01/31/1997  
(277) Ophthalmoscope Guidance ODE/DOED/DSDB 1241 07/08/1998  
(278) Slit Lamp Guidance; Final ODE/DOED/DSDB 1242 07/08/1998  
(279) Guidance Document for Nonprescription Sunglasses; Final ODE/DOED/DSDB 2208 10/09/1998  
(280) Retinoscope Guidance; Final ODE/DOED/DSDB 1240 07/08/1998  
(281) Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [excimer] ODE/DOED/DSDB 2093 10/10/1996  
(282) Information for Keratome Manufacturers Regarding LASIK; Final Guidance for Industry ODE/DOED/DSDB 1376 06/21/2001  
(283) Guidance for Industry and FDA Staff - Keratome and Replacement Keratome Blades Premarket Notification [510(k)] Submissions ODE/DOED/DSDB 1604 09/18/2006  
(284) Guidance for Industry and FDA Staff: Tonometers - Premarket Notification [510(k)] Submissions ODE/DOED/DSDB 1593 03/27/2006  
(285) Tinnitus Masker Devices - Class II Special Controls Guidance Document - Draft Guidance for Industry and FDA Staff ODE/DOED/ENTB 1555 11/08/2005  
(286) Guidance for Industry and FDA Staff: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products ODE/DOED/ENTB 1696 02/25/2009  
(287) Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Olfactory Test Device ODE/DOED/ENTB 1595 06/07/2006  
(288) Implantable Middle Ear Hearing Device; Guidance for Industry and FDA ODE/DOED/ENTB 1406 08/01/2003  
(289) Class II Special Controls Guidance Document: Endolymphatic Shunt Tube with Valve; Guidance for Industry and FDA ODE/DOED/ENTB 791 04/29/2002  
(290) Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS); Guidance for Industry and FDA ODE/DOED/ENTB 1414 11/07/2002  
(291) Tympanostomy Tubes, Submission Guidance for a 510(k) Premarket Notification; Final ODE/DOED/ENTB 930 01/14/1998 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080204.pdf]   
(292) Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers; Final ODE/DOED/ENTB 954 03/12/2000  
(293) Vocal Fold Medialization Devices - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff ODE/DOED/ENTB 1535 02/13/2004  
(294) Important Information About Rophae Intraocular Lenses ODE/DOED/ICIB 811 08/20/1992  
(295) Guidance on 510(k) Submissions for Keratoprostheses, Final ODE/DOED/ICIB 1351 03/03/1999  
(296) Aqueous Shunts - 510(k) Submissions; Final ODE/DOED/ICIB 2236 11/16/1998  
(297) Revised Procedures for Adding Lens Finishing Laboratories to Approved Premarket Approval Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear; Final ODE/DOED/VEDB 1249 08/11/1998  
(298) Guidance for Premarket Submissions of Orthokeratology Rigid Gas Permeable Contact Lenses; Final ODE/DOED/VEDB 1134 04/10/2000  
(299) Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses ODE/DOED/VEDB 896 06/28/1994  
(300) Premarket Notification 510(k) Guidance for Contact Lens Care Products ODE/DOED/VEDB 674 05/01/1997 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080218.pdf]   
(301) New FDA Recommendations & Results of Contact Lens Study (7 day letter) ODE/DOED/VEDB 265 05/30/1989  
(302) Draft Guidance for Industry and FDA Staff: Investigational Device Exemption (IDE) Guidance for Retinal Prostheses ODE/DOED/VEDB 1651 04/17/2009  
(303) Guidance for the Submission of Premarket Notifications for Radionuclide Dose Calibrators; Final ODE/DRARD 2238 11/20/1998  
(304) Reviewer Guidance for Automatic X-Ray Film Processor 510(k) ODE/DRARD 788 02/01/1990  
(305) Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices; Final ODE/DRARD 644 08/06/1999  
(306) Harmonic Imaging with/without Contrast - Premarket Notification; Final ODE/DRARD 2234 11/16/1998  
(307) Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Final ODE/DRARD 340 11/14/1998  
(308) Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems; Final ODE/DRARD 2240 12/03/1998  
(309) Letter: Notice to Manufacturers of Bone Mineral Densitometers ODE/DRARD 552 09/25/1997  
(310) Bone Sonometer PMA Applications; Final Guidance for Industry and FDA ODE/DRARD 1377 06/21/2001  
(311) Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and FDA Staff ODE/DRARD 793 07/14/2003  
(312) Implanted Blood Access Devices for Hemodialysis - Draft Guidance for Industry and Food and Drug Administration Staff ODE/DRARD 1781 06/28/2013  
(313) Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDA ODE/DRARD 983 02/16/2001  
(314) Guidance for the Submission of Premarket Notifications for Medical Image Management Devices ODE/DRARD 416 07/27/2000  
(315) Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources ODE/DRARD 1177 08/02/2000  
(316) Guidance for Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport, and Storage of Organs for Transplantation; Final Guidance for Industry and FDA Reviewers ODE/DRARD/GRDB 1164 01/16/2001  
(317) Guidance for Industry and FDA Staff: Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis ODE/DRARD/GRDB 1650 04/15/2008  
(318) Class II Special Controls Guidance Document: Tissue Culture Media for Human ex vivo Tissue and Cell Culture Processing Applications; Final Guidance for Industry and FDA Reviewers ODE/DRARD/GRDB 1325 05/16/2001  
(319) Class II Special Controls Guidance Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA ODE/DRARD/GRDB 1385 11/28/2001  
(320) Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis ODE/DRARD/GRDB 842 05/30/1997  
(321) Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems; Final ODE/DRARD/GRDB 2202 08/07/1998  
(322) Guidance for the Content of Premarket Notification for Conventional and High Permeability Hemodialyzers; Final ODE/DRARD/GRDB 421 08/07/1998  
(323) Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents; Final ODE/DRARD/GRDB 2243 02/05/1998  
(324) Guidance for Industry and FDA Staff: Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions ODE/DRARD/GRDB 1649 04/23/2008  
(325) Guidance for Industry: Designation of Special Controls for Male Condoms Made of Natural Rubber Latex (21 CFR 884.5300); Small Entity Compliance Guide ODE/DRARD/OGDB 1693 01/05/2009  
(326) Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems ODE/DRARD/OGDB 1539 12/28/2004  
(327) Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) ODE/DRARD/OGDB 166 07/27/2005  
(328) Uniform Contraceptive Labeling; Final ODE/DRARD/OGDB 1251 07/23/1998  
(329) Hysteroscopes and Laparoscopic Insufflators: Submission Guidance for a 510(k) ODE/DRARD/OGDB 1907 08/01/1995  
(330) Letter to Manufacturers of Falloposcopes ODE/DRARD/OGDB 1344 09/05/1996  
(331) Letter to Manufacturers of Prescription Home Monitors for Non-Stress Tests ODE/DRARD/OGDB 1342 09/06/1996  
(332) Latex Condoms for Men - Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions ODE/DRARD/OGDB 1250 07/23/1998 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073947.htm]   
(333) Thermal Endometrial Ablation Devices (Submission Guidance for an IDE) ODE/DRARD/OGDB 547 03/14/1996  
(334) Guidance ('Guidelines') for Evaluation of Fetal Clip Electrode ODE/DRARD/OGDB 244 03/08/1977  
(335) Guidance ('Guidelines') for Evaluation of Hysteroscopic Sterilization Devices ODE/DRARD/OGDB 248 05/10/1978  
(336) Guidance ('Guidelines') for Evaluation of Laparoscopic Bipolar and Thermal Coagulators (and Accessories) ODE/DRARD/OGDB 232 05/01/1978  
(337) Guidance ('Guidelines') for Evaluation of Tubal Occlusion Devices ODE/DRARD/OGDB 245 11/22/1977  
(338) Guidelines for Evaluation of Non-Drug IUDs ODE/DRARD/OGDB 641 09/28/1976  
(339) Hysteroscopes and Gynecology Laparoscopes - Submission Guidance for a 510(k) ODE/DRARD/OGDB 907 03/07/1996  
(340) Premarket Testing Guidelines for Female Barrier Contraceptive Devices also intended to prevent sexually transmitted diseases ODE/DRARD/OGDB 384 04/04/1990  
(341) Testing guidance for Male Condoms Made from New Material (Non-Latex) ODE/DRARD/OGDB 455 06/29/1995  
(342) Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Guidance for Industry ODE/DRARD/OGDB 1356 06/18/2002  
(343) Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems ODE/DRARD/OGDB 1625 04/24/2007  
(344) Class II Special Controls Guidance Document: Breast Lesion Documentation System - Guidance for Industry and FDA Staff ODE/DRARD/OGDB 1202 07/28/2003  
(345) Class II Special Controls Guidance for Home Uterine Activity Monitors; Final Guidance for Industry and FDA Reviewers ODE/DRARD/OGDB 820 03/09/2001 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM073596.pdf]   
(346) Class II Special Controls Guidance Document for Clitoral Engorgement Devices ODE/DRARD/OGDB 1144 07/03/2000  
(347) Vascular and Neurovascular Embolization Devices - Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff ODE/DRARD/OGDB
ODE/DGRND/PRSB
ODE/DCD/PVDB
1234 12/29/2004  
(348) Guidance for Industry and Food and Drug Administration Staff - Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH) ODE/DRARD/ULDB 1724 08/17/2010  
(349) Guidance for Industry and FDA Staff - Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence ODE/DRARD/ULDB 1636 09/19/2008 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070852.htm]   
(350) Class II Special Controls Guidance Document: External Penile Rigidity Devices ODE/DRARD/ULDB 1231 12/28/2004  
(351) Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters; Final ODE/DRARD/ULDB 2235 11/30/1998  
(352) 510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments ODE/DRARD/ULDB 892 09/19/1994  
(353) Checklist for Mechanical Lithotripters and Stone Dislodgers used in Gastroenterology and Urology ODE/DRARD/ULDB 98 11/01/1994 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080794.pdf]   
(354) Draft Guidance for Preparation of PMA Applications for Testicular Prostheses ODE/DRARD/ULDB 809 03/16/1993  
(355) Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology ODE/DRARD/ULDB 482 02/10/1993  
(356) Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters ODE/DRARD/ULDB 97 09/12/1994  
(357) Guidance for the Content of Premarket Notifications for Ureteral Stents ODE/DRARD/ULDB 431 02/10/1993  
(358) Guidance for the Content of Premarket Notifications for Urine Drainage Bags ODE/DRARD/ULDB 96 06/07/1994 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080999.pdf]   
(359) Guidance for the Content of Premarket Notifications for Urodynamic/Uroflowmetry Systems ODE/DRARD/ULDB 490 07/29/1994  
(360) Guidance for the Content of Premarket Notifications for Penile Rigidity Implants; Final ODE/DRARD/ULDB 177 01/16/2000  
(361) Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi ODE/DRARD/ULDB 1226 08/09/2000  
(362) Guidance for Industry and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers ODE/ODEOD/POS 1381 07/18/2006  
(363) Premarket Approval Application Filing Review - Guidance for Industry and FDA Staff OIVD
ODE
297 05/01/2003  
(364) Guidance for Third Parties and FDA Staff; Third Party Review of Premarket Notifications OIVD
ODE
2237 09/28/2004  
(365) Format for Traditional and Abbreviated 510(k)s - Guidance for Industry and FDA Staff OIVD
ODE
1567 08/12/2005  
(366) Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff CBER
OIVD
ODE
337 05/11/2005  
(367) Draft Guidance for Industry and FDA Staff - Recommended Warning for Surgeon's Gloves and Patient Examination Gloves that Use Powder OSEL
ODE
1704 02/07/2011  
(368) Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions OSEL
ODE/DRARD
1617 05/30/2008 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm107549.htm]   
(369) Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Bone Sonometers OSEL
ODE/DRARD
1547 07/16/2008 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm084354.htm]   
(370) Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers OSEL
ODE/DRARD
560 09/09/2008  
(371) Dental Curing Lights - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff OSEL/DPS
ODE/DAGID/DEDB
1591 03/27/2006 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm107711.htm]   
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