Items added to the FDA's Center for Devices and Radiological Health website within the last month. http://www.fda.gov/cdrh/newpg.html en-us Sat, 18 May 2013 02:26:15 GMT webo@cdrh.fda.gov http://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm070591.gif http://www.fda.gov/MedicalDevices/default.htm The FDA is announcing the availability of the draft guidance entitled 'Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A.' This draft document provides CDRH's proposed interpretation of key provisions of Fri, 17 May 2013 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2013-05-17/html/2013-11708.htm The FDA is announcing the availability of the guidance entitled 'Center for Devices and Radiological Health (CDRH) Appeals Processes.' This document describes the processes available to outside stakeholders to request additional review of decisions or... Fri, 17 May 2013 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2013-05-17/html/2013-11706.htm The cobas® EGFR Mutation Test is an automated molecular assay designed to detect the presence of mutations in the epidermal growth factor receptor (EGFR) gene in cancer-spreading (metastatic) non-small cell lung cancer (NSCLC). Fri, 17 May 2013 04:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm352932.htm Labeling, Approval Order, and Summary of Safety and Effectiveness for cobas® EGFR Mutation Test (P120019). Fri, 17 May 2013 04:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P120019 This document has the following purposes: (1) develop a common understanding of the statutory criteria for granting expedited review to premarket submissions for medical devices, and (2) outline standard procedures that should be followed to achieve an... Fri, 17 May 2013 04:00:00 GMT http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089643.htm Meeting materials posted for May 21-22, 2013 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Fri, 17 May 2013 04:00:00 GMT http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/ucm352525.htm Labeling, Approval Order, and Summary of Safety and Effectiveness for VASCADE Vascular Closure System (VCS) (P120016). Fri, 17 May 2013 04:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P120016 This guidance document describes the processes available to outside stakeholders to request additional review of decisions or actions by CDRH employees. Thu, 16 May 2013 04:00:00 GMT http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm284651.htm This draft guidance document provides CDRH proposed interpretation of key provisions of Section 517A of the Food, Drug and Cosmetic Act (FD&C Act), which was added by section 603 of the FDA Safety and Innovation Act (FDASIA) of 2012, as those provisions.. Thu, 16 May 2013 04:00:00 GMT http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm352248.htm The FDA classifying the ingestible event marker into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Thu, 16 May 2013 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2013-05-16/html/2013-11628.htm This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Dental Products Panel of the Medical Devices Advisory Committee. Mon, 13 May 2013 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2013-05-13/html/2013-11286.htm Meeting Announcement: July 18, 2013 Dental Products Panel of the Medical Devices Advisory Committee Mon, 13 May 2013 04:00:00 GMT http://www.fda.gov/AdvisoryCommittees/Calendar/ucm351380.htm Transcript posted for April 8, 2013 Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Mon, 13 May 2013 04:00:00 GMT http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OphthalmicDevicesPanel/UCM352017.pdf The FDA is announcing that a collection of information entitled 'Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable' has been approved by the Office of Management and Fri, 10 May 2013 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2013-05-10/html/2013-11125.htm The FDA is proposing to reclassify ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and to rename them sunlamp products Thu, 09 May 2013 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2013-05-09/html/2013-10982.htm The FDA is announcing the public meeting entitled '510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.' The focus of this meeting is FDA's interpretation of its regulations concerning when a modification made Wed, 08 May 2013 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2013-05-08/html/2013-10888.htm Meeting Announcement: June 13, 2013 Microbiology Devices Panel of the Medical Devices Advisory Committee Wed, 08 May 2013 04:00:00 GMT http://www.fda.gov/AdvisoryCommittees/Calendar/ucm351035.htm This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Wed, 08 May 2013 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2013-05-08/html/2013-10891.htm Labeling, Approval Order, and Summary of Safety and Effectiveness for SEDASYS® Computer-Assisted Personalized Sedation System (P080009). Wed, 08 May 2013 04:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P080009 24 Hour Summary and Presentations posted for May 2, 2013 General and Plastic Surgery Devices Panel of the Medical Devices Meeting Tue, 07 May 2013 04:00:00 GMT http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/ucm349426.htm Cardinal Health discovered that various Presource Kits containing a pre-assembled anesthesia circuit and filter may contain outer plastic packaging on one or more components. Tue, 07 May 2013 04:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm350996.htm The FDA is issuing this communication to alert you about Covidien Endo GIA Articulating 60-3.5 Surgical Stapler Reloads that were labeled sterile but were stolen from the manufacturer prior to product sterilization. Tue, 07 May 2013 04:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm351019.htm Reason for Recall: Some battery modules distributed after Jan. 31, 2010 have a shorter battery run time than expected. This can result in unexpected ventilator shut downs, which can result in serious adverse health consequences, including death. Tue, 07 May 2013 04:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm351092.htm There is a potential for damage due to the use of the lead cap provided in DBS and Dystonia kits. Tue, 07 May 2013 04:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm351000.htm The Perclose ProGlide Suture-Mediated Closure (ProGlide SMC) System is designed to deliver a single monofilament2 polypropylene suture to close a femoral artery (a major artery in the thigh) puncture site following diagnostic or interventional... Tue, 07 May 2013 04:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm351099.htm Labeling, Approval Order, and Summary of Safety and Effectiveness for Perclose ProGlide Suture-Mediated Closure System (ProGlide SMC) (P960043S080). Tue, 07 May 2013 04:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P960043S080 Transcript posted for April 11, 2013 Device Good Manufacturing Practice Advisory Committee Meeting Tue, 07 May 2013 04:00:00 GMT http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/DeviceGoodManufacturingPracticeAdvisoryCommittee/UCM350772.pdf The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register... Mon, 06 May 2013 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2013-05-06/html/2013-10597.htm Meeting Announcement: June 27, 2013 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Fri, 03 May 2013 04:00:00 GMT http://www.fda.gov/AdvisoryCommittees/Calendar/ucm350324.htm Obesity is a major public health concern in the United States and has been linked to many health problems such as heart disease, stroke, diabetes, high blood pressure, sleep disorders, and breathing problems. Obesity (an excessive amount of body fat)... Fri, 03 May 2013 04:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ObesityDevices/default.htm The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Thu, 02 May 2013 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2013-05-02/html/2013-10376.htm This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Thu, 02 May 2013 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2013-05-02/html/2013-10394.htm The FDA is announcing that a collection of information entitled 'Medical Devices; Inspection by Accredited Persons Program' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. Wed, 01 May 2013 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2013-05-01/html/2013-10248.htm Damage from Battery Leakage May Cause the Device to Shut Off Without Warning. Wed, 01 May 2013 04:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm350397.htm The recall is in response to customer reports of Newport Medical Instrument?s HT70 Ventilator and HT70 Plus Ventilator alarming and going into internal backup battery sooner than expected, while the ventilator is being operated on Power Pac battery. Wed, 01 May 2013 04:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm350424.htm The purpose of the meeting is to discuss FDA?s past, present, and future policy on 510(k) Modifications with external stakeholders. FDA seeks comment from stakeholders on different options, both in the form of submissions to the docket for the Federal... Tue, 30 Apr 2013 04:00:00 GMT http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm347888.htm Meeting materials posted for May 2, 2013 General and Plastic Surgery Devices Panel of the Medical Devices Meeting Tue, 30 Apr 2013 04:00:00 GMT http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/ucm349426.htm Battery failure resulting in delay/interruption of therapy and loss of data. Mon, 29 Apr 2013 04:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm349866.htm This guidance presents a least burdensome regulatory approach to gain FDA approval of Class III or certain licensed in vitro diagnostic devices... Thu, 25 Apr 2013 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2013-04-25/html/2013-09759.htm Meeting Announcement: July 24-25, 2013 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Thu, 25 Apr 2013 04:00:00 GMT http://www.fda.gov/AdvisoryCommittees/Calendar/ucm349379.htm This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Thu, 25 Apr 2013 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2013-04-25/html/2013-09744.htm This guidance outlines FDA's regulatory approach for approval of Class III in vitro diagnostic devices, as well as certain licensed or certain cleared in vitro diagnostic devices in cases, when a previously approved, licensed, or cleared assay is... Wed, 24 Apr 2013 04:00:00 GMT http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm092752.pdf The Ceramax Ceramic Hip System is a ceramic-on-ceramic artificial hip replacement system, surgically implanted to completely replace a hip joint. Wed, 24 Apr 2013 04:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm349307.htm Labeling, Approval Order, and Summary of Safety and Effectiveness for DePuy Ceramax Ceramic Total Hip System (P070026S004). Wed, 24 Apr 2013 04:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P070026S004 Reason for Recall: The mask inside the package has been identified as 'Neonatal' in size and not 'Infant' as the labeling indicates. The use of an improperly-sized mask may cause serious adverse health consequences, including death. Wed, 24 Apr 2013 04:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm349294.htm The Giraffe Incubator and Giraffe OmniBed may randomly delete stored information and enter new information in its place (over-write) when the device turns ?on? or recovers from a power failure. When this occurs, the heater or oxygen delivery option... Wed, 24 Apr 2013 04:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm349245.htm The TECNIS Toric 1-Piece Intraocular Lens (IOL) is an artificial lens used to correct corneal astigmatism (a football-shaped cornea or an irregularly shaped cornea) and restore distance vision after removal of the natural lens of the eye during cataract.. Wed, 24 Apr 2013 04:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm349308.htm Labeling, Approval Order, and Summary of Safety and Effectiveness for TECNIS® Toric 1-Piece Intraocular Lens (IOL) and the TECNIS® Toric Calculator System (P980040S039). Wed, 24 Apr 2013 04:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P980040S039 The FDA is announcing that a collection of information entitled "Investigational Device Exemptions Reports and Records' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. Tue, 23 Apr 2013 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2013-04-23/html/2013-09481.htm The MedWatcher app makes it easier and faster for healthcare professionals, patients and caregivers to send voluntary reports of medical device problems to the FDA, compared to the traditional reporting methods - mail, phone or online. Tue, 23 Apr 2013 04:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/FormsandInstructions/ucm348271.htm This test is for the presumptive detection of novel influenza A (H7N9) virus in conjunction with the FDA cleared CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel in real-time RT-PCR (rRT-PCR) assays in patients with signs and symptoms of... Tue, 23 Apr 2013 04:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm Through its premarket review process, the FDA makes every effort to assure that risks associated with medical devices have been minimized when those devices first enter the market. However, once medical devices are widely used by health care providers and Tue, 23 Apr 2013 04:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/CDRHPostmarketSurveillance/default.htm FDA invites consumers to get involved in the process of helping FDA make the decisions that affect their lives. Tue, 23 Apr 2013 04:00:00 GMT http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm348661.htm Failure to provide a warning at extremely high blood glucose levels. Tue, 23 Apr 2013 04:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm349127.htm Meeting materials posted for April 25, 2013 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee meeting Tue, 23 Apr 2013 04:00:00 GMT http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ClinicalChemistryandClinicalToxicologyDevicesPanel/ucm348933.htm The FDA is announcing the extension of the Early Feasibility Study Investigational Device Exemption (IDE) Applications pilot program to May 8, 2014, for sponsors who have already been accepted for the program. Tue, 23 Apr 2013 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2013-04-23/html/2013-09528.htm The FDA is announcing the availability of the draft guidance entitled "Use of International Standard ISO-10993, `Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.' 'FDA has developed this guidance document to assist industry in... Tue, 23 Apr 2013 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2013-04-23/html/2013-09479.htm Reason for Recall: CareFusion has received reports of a communication error on the Alaris PC unit (model 8015) with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached. Use of this product may cause serious adverse... Mon, 22 Apr 2013 04:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm348983.htm Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes (New Memos Available) Mon, 22 Apr 2013 04:00:00 GMT http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm206289.htm FDA has developed this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exemptions (HDEs), Investigational Device Applications (IDEs), Premarket Notifications (510(k)s), and de novo requests for... Mon, 22 Apr 2013 04:00:00 GMT http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM348890.pdf The FDA is announcing that a collection of information entitled "Electronic Submission of Medical Device Registration and Listing' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. Fri, 19 Apr 2013 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2013-04-19/html/2013-09182.htm The FDA is announcing that a collection of information entitled ``Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business Qualification and Certification' has been approved by the Office of... Fri, 19 Apr 2013 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2013-04-19/html/2013-09181.htm The FDA is alerting health care providers, health care facility staff, and caregivers that damaged or worn covers for medical bed mattresses can allow blood and body fluids to penetrate medical bed mattresses, posing a risk of infection to patients. Fri, 19 Apr 2013 04:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm348016.htm The FDA is proposing to revise medical device and biological product labeling regulations to explicitly allow for the inclusion of stand-alone graphical representations of information, or symbols, if the symbol has been established as part of a standard.. Fri, 19 Apr 2013 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2013-04-19/html/2013-09175.htm