Fda Retracts Medical Device

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

FDA Issues Two Warning Letters to Leading Manufacturer of Endoscopes CDRH recently issued two warning letters to a leading manufacturer of endoscopes, Olympus Medical Systems Corporation, and...

Device Approvals, Denials and Clearances | FDA

https://www.fda.gov/medical-devices/products-and-medical-procedures/device-approvals-denials-and-clearances

A PMA is an application submitted to FDA to request approval to market. Unlike premarket notification, PMA approval is to be based on a determination by FDA that the PMA …

3 Experts Quit An FDA Panel Over Alzheimer's Drug …

https://www.npr.org/2021/06/11/1005567149/3-experts-have-resigned-from-an-fda-committee-over-alzheimers-drug-approval

The drug — its generic name is aducanumab — was approved on Monday, setting off a variety of responses, from celebrations among some patients, caregivers and …

Recalls, Corrections and Removals (Devices) | FDA

https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices

Medical Device Recalls | FDA

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls

If you wish to find information on a recall, or a correction or removal action that has not yet been classified, you can search the Medical Device Recalls Database. …

Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices …

Importing Medical Devices | FDA

https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices

The FDA maintains public 510 (k) and PMA databases. You can search the releasable 510 (k) and PMA databases to obtain 510 (k) and PMA information for a specific product. …

Reprocessing of Reusable Medical Devices: Information …

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/reprocessing-reusable-medical-devices-information-manufacturers

In March 2015, the Agency published Final Guidance for Industry and FDA Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.

Revoked EUAs for Non-NIOSH-Approved Disposable FFRs

https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/revoked-euas-non-niosh-approved-disposable-filtering-facepiece-respirators

On March 24, 2020, the FDA issued an umbrella EUA for certain imported disposable filtering facepiece respirators (FFRs) that are not approved by the National Institute for …

Not So Fast – FDA Retracts Authorization for Some Respirators …

https://www.fdalawblog.com/2020/05/articles/coronavirus/prep-respirators-made-in-china/

But last week, the Food and Drug Administration (“FDA”) took a significant step back, retracting its Emergency Use Authorization (“EUA”) for respirators from 75 …