Fda Medical Device Recall Decision Tree

Medical Device Recalls | FDA

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

The FDA posts summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health...

Recalls, Corrections and Removals (Devices) | FDA

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

2022 Medical Device Recalls | FDA

https://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls

2021 Medical Device Recalls Subscribe to Medical Device Safety and Recalls Sign up to receive email updates on medical device recalls, safety communications, and other …

Medical Device Recalls - Food and Drug Administration

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm

Medical Device Reporting (MDR): How to Report Medical …

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

In the Federal Register of December 26, 2017 ( 82 FR 60922 ), the FDA issued a notification outlining the FDA's proposal to grant an alternative under 21 CFR 803.19 to permit …

CHAPTER 7 - RECALL ACTIVITIES - Food and …

https://www.fda.gov/media/75263/download

The FDA may consider an order of retention, recall, destruction, or cessation of manufacturing when any of the conditions specified in 21 CFR 1271.440 (a)(1) to (3) exist. …

Deciding When to Submit a 510 (k) for a Change to an …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device

Almost from the enactment of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) in 1976, the Food and Drug Administration (FDA or the …

What is a Medical Device Recall? | FDA

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

In most cases, a company (manufacturer, distributor, or other responsible party) recalls a medical device on its own (voluntarily). When a company learns that it has a product that …

Medical Device Reporting | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/medical-device-reporting

The Medical Device Reporting (MDR) Regulation requires medical device manufacturers, device user facilities and importers to establish a system that ensures the prompt …

eCFR :: 21 CFR Part 810 -- Medical Device Recall Authority

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-810

( 1) Recall of a device from individuals; or ( 2) Recall of a device from device user facilities, if FDA determines that the risk of recalling the device from the facilities presents a greater …