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Food and Drug Adminstration (FDA): CDRHNew



Items added to the FDA's Center for Devices and Radiological Health website within the last month.



Last Build Date: Tue, 06 Dec 2016 06:11:44 GMT

 



Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Providing Information About Pediatric Uses of Medical Devices

Mon, 05 Dec 2016 05:00:00 GMT

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 concer...



Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Recommended Glossary and Educational Outreach To Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use

Mon, 05 Dec 2016 05:00:00 GMT

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 concer...



Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device: Current Good Manufacturing Practice Quality System Regulations

Mon, 05 Dec 2016 05:00:00 GMT

The FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.



A Message from the Director, Division of Mammography Quality Standards (DMQS): EQUIP

Fri, 02 Dec 2016 05:00:00 GMT

First, I want to thank everyone for the very positive feedback we have received about the series of articles on MQSA topics which we launched in 2015. We are glad that you have found them informative and relevant. You can send any suggestions for...



MQSA National Statistics

Thu, 01 Dec 2016 05:00:00 GMT

In this section of MQSA Insights, we present the most commonly requested national statistics regarding the MQSA program. These statistics are updated on the first of each month.



Transcripts posted for November 9-10, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee

Thu, 01 Dec 2016 05:00:00 GMT

Transcripts posted for November 9-10, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee



Class I Medical Device Recall: Medtronic Recalls Neurovascular Products due to Potential Separation and Detachment of Polytetrafluoroethylene (PTFE) Coating

Wed, 30 Nov 2016 05:00:00 GMT

Medtronic is recalling of certain lots of its Pipeline embolization device, Alligator retrieval device, X-Celerator hydrophilic guidewire, and UltraFlow and Marathon flow-directed micro catheters.



Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140040 added)

Tue, 29 Nov 2016 05:00:00 GMT

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140040 added)



Federal Register: Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes; Guidance for Industry and Food and Drug Administration Staff; Availability

Tue, 29 Nov 2016 05:00:00 GMT

The FDA is announcing the availability of the guidance ``Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes.'' Flexible gastrointestinal endoscopes and accessories are...



Presentation and Transcript added to Webinar - Final Guidance Documents: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use and Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use - November 21, 2016

Tue, 29 Nov 2016 05:00:00 GMT

On Monday, November 21, 2016, the FDA hosted a webinar to share information and answer questions about the final guidance documents: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use and Blood Glucose Monitoring Test Systems for...



Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in the Medical Device Fellowship Program

Mon, 28 Nov 2016 05:00:00 GMT

The FDA is announcing that a proposed collection of information - Application for Participation in the Medical Device Fellowship Program - has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Redu...



Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes - Guidance for Industry and Food and Drug Administration Staff

Mon, 28 Nov 2016 05:00:00 GMT

The objectives of this guidance document are to: 1) highlight the cross-contamination risk associated with specific types of irrigation valves and accessories when used with flexible gastrointestinal endoscopes; 2) clarify terminology used to describe...



LASIK Quality of Life Collaboration Project

Wed, 23 Nov 2016 05:00:00 GMT

In October 2009, the FDA, the National Eye Institute (NEI), and the Department of Defense (DoD) launched the LASIK Quality of Life Collaboration Project (LQOLCP) to help better understand the potential risk of severe problems that can result from LASIK.



Emergency Use Authorizations: Abbott RealTime Zika

Tue, 22 Nov 2016 05:00:00 GMT

On November 21, 2016, the FDA issued an Emergency Use Authorization (EUA) for emergency use of Abbott’s RealTime Zika assay for the qualitative detection of RNA from Zika virus in human serum, EDTA plasma and urine (collected alongside a patient-matched



Class I Medical Device Recall: SentreHeart Recalls FindrWIRZ Guidewire System due to Coating Separation

Tue, 22 Nov 2016 05:00:00 GMT

SentreHeart is recalling the FindrWIRZ Guidewire System because the PTFE coating may separate (e.g., peel, flake, shed, delaminate, slough off) from the packaging and potentially cause serious injuries to patients. Coating separation may be caused by...



Webcast and Presentations added to Public Workshop on Promoting Semantic Interoperability of Laboratory Data, November 8, 2016

Tue, 22 Nov 2016 05:00:00 GMT

The Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Library of Medicine (NLM) of the National Institutes of Health (NIH), the Office of the National Coordinator for Health Information Technology...



Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification

Fri, 18 Nov 2016 05:00:00 GMT

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 concer...



Essure Labeling Information for Patients and Health Care Providers (Updated)

Fri, 18 Nov 2016 05:00:00 GMT

The original Essure labeling has changed several times since approval in 2002 based on PMA supplements submitted to the FDA and to align with recommendations in the final guidance, Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended...



Federal Register: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

Fri, 18 Nov 2016 05:00:00 GMT

The FDA is announcing the availability of the guidance ``Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.'' This guidance provides a detailed description of the information that should be included in a premarket notifica...



24 HourSummary posted for November 10, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee

Thu, 17 Nov 2016 05:00:00 GMT

24 HourSummary posted for November 10, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee



Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff

Thu, 17 Nov 2016 05:00:00 GMT

This guidance document provides a detailed description of the information that should be included in a premarket notification for a magnetic resonance diagnostic device (MRDD). This document is a recommendation of how to comply with certain...



24 HourSummary posted for November 9, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee

Wed, 16 Nov 2016 05:00:00 GMT

24 HourSummary posted for November 9, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee



Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150049 added)

Wed, 16 Nov 2016 05:00:00 GMT

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150049 added)



Class I Medical Device Recall: HeartWare Recalls Ventricular Assist Device Controllers Due to Loose Connector Ports

Wed, 16 Nov 2016 05:00:00 GMT

HeartWare Inc. is recalling the HVAD controller due to a loose power connector which may cause the rear portion of the pump’s driveline connector to become separated from the front portion of the driveline connector. A loose connector may allow moisture..



Class I Medical Device Recall: HeartWare Recalls Ventricular Assist Device Pumps Due to Contamination Causing Electrical Issues

Wed, 16 Nov 2016 05:00:00 GMT

HeartWare Inc. is recalling the HVAD pumps due to a design problem with the driveline connector. The driveline is a tube that connects the HVAD’s pump to the external controller and power source. Contamination of the driveline may result in fluid or other



Check the CDRH Customer Satisfaction Results

Tue, 15 Nov 2016 05:00:00 GMT

This page provides real time results for CDRH's customer satisfaction survey.



Presentations posted for November 9-10, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee

Tue, 15 Nov 2016 05:00:00 GMT

Presentations posted for November 9-10, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee



Updated Essure Activities and Information for Patients and Providers

Tue, 15 Nov 2016 05:00:00 GMT

Update on the status of FDA’s evaluation of the Essure System.



Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Products

Thu, 10 Nov 2016 05:00:00 GMT

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 Federal Agencies are required to publish notice in the Federal Register concerning each p...



Neurological Devices

Thu, 10 Nov 2016 05:00:00 GMT

Neurological devices are medical devices that are intended to diagnose, slow, stop, or reverse the effects of neurological diseases and disorders. Some examples include the treatment of conditions such as Alzheimer’s disease, Parkinson’s disease...



Federal Register: Product Labeling for Certain Ultrasonic Surgical Aspirator Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Thu, 10 Nov 2016 05:00:00 GMT

The FDA is announcing the availability of the draft guidance ``Product Labeling for Certain Ultrasonic Surgical Aspirator Devices.'' FDA is providing a specific labeling recommendation in this guidance to promote the safe and effective use of ultrasoni...



Product Labeling for Certain Ultrasonic Surgical Aspirator Devices - Draft Guidance for Industry and Food and Drug Administration Staff

Wed, 09 Nov 2016 05:00:00 GMT

The FDA is issuing this draft guidance to recommend the addition of a specific safety statement to the product labeling of certain ultrasonic surgical aspirator devices. Ultrasonic surgical aspirator devices are surgical tools intended to fragment...



Transcripts posted for October 25-26, 2016 Technical Electronic Product Radiation Safety Standards Committee

Wed, 09 Nov 2016 05:00:00 GMT

Transcripts posted for October 25-26, 2016 Technical Electronic Product Radiation Safety Standards Committee



Federal Register: Medical Device Reporting for Manufacturers; Guidance for Industry and Food and Drug Administration Staff; Availability

Tue, 08 Nov 2016 05:00:00 GMT

The FDA is announcing the availability of the guidance ``Medical Device Reporting for Manufacturers; Guidance for Industry and Food and Drug Administration Staff.'' This guidance document is intended to assist medical device manufacturers meet applicab...



Federal Register: Clinical Considerations for Investigational Device Exemptions for Neurological Devices Targeting Disease Progression and Clinical Outcomes; Guidance for Industry and Food and Drug Administration Staff; Availability

Mon, 07 Nov 2016 05:00:00 GMT

The FDA is announcing the availability of the guidance ``Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes.'' The Center for Devices and Radiological Healt...



Federal Register: Establishment of the Patient and Care-Partner Connection; Establishment of a Public Docket; Request for Comments

Mon, 07 Nov 2016 05:00:00 GMT

The FDA is establishing a public docket to receive input on the new Center for Devices and Radiological Health's program 'The Patient and Care-partner Connection (P&CC)'. P&CC will partner with patient organizations to provide a means for CDRH staff to...



Medical Device Reporting for Manufacturers - Guidance for Industry and Food and Drug Administration Staff

Mon, 07 Nov 2016 05:00:00 GMT

The MDR regulation provides a mechanism that allows us (the FDA), as well as you (the device manufacturer), to identify and monitor adverse events (deaths and serious injuries) and certain malfunctions involving your medical devices.



Meeting materials posted for November 9-10, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee

Mon, 07 Nov 2016 05:00:00 GMT

Meeting materials posted for November 9-10, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee



MRI Safety Posters

Mon, 07 Nov 2016 05:00:00 GMT

In partnership with the Society for Magnetic Resonance Technologists (SMRT), the FDA has developed a series of posters addressing MRI safety key aspects for MR technologists and other site personnel.



Webinar - Final Guidance on Medical Device Reporting for Manufacturers - November 30, 2016

Mon, 07 Nov 2016 05:00:00 GMT

On Monday November 7, 2016, the FDA issued final guidance on Medical Device Reporting for Manufacturers. This guidance document is intended to assist medical device manufacturers meet applicable reporting and recordkeeping requirements for certain...