Relationship between "Corrections/Removals" procedure and "Recall" procedure

[Alexander Gaffney]

@OP and others: FDA just released a new draft guidance document on this very topic.

This is account is too new to post links, but Google:

"Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements - Draft Guidance for Industry and Food and Drug Administration Staff"

and you'll find that guidance rather quickly.


The guidance is really geared toward answering some of the more common questions asked in this thread, so you might find it useful.

Best,

Alec

 

[Ronen E]

@OP and others: FDA just released a new draft guidance document on this very topic.

This is account is too new to post links, but Google:

"Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements - Draft Guidance for Industry and Food and Drug Administration Staff"

and you'll find that guidance rather quickly.


The guidance is really geared toward answering some of the more common questions asked in this thread, so you might find it useful.

Best,

Alec

Here's the link:

http ://www .fda. gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm340518.htm - DEAD 404 LINK UNLINKED

Thanks for sharing and welcome to the Cove.
Ronen.