Annual Product Review required for Medical Device (21CFRpart 820)?

Bev D

Heretical Statistician
Leader
Super Moderator
Just one more straw for the camel's back...

Risk Management (14971) expects some postmarket review to ensure your Risk File is up-to-date. This includes consideration regarding state of the art.
? Not sure why this is bad? You should do it to make sure your product is working. The paperwork is just (silly) objective evidence.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
We do annual Risk Review. We do review the MAUDA database. From a practical standpoint all med dev companies should do that too. FDA has been known to see trends in certain product categories and apply them to the entire product code under its purview. They will then go out and audit all manufacturers to see if they are addressing this new trend too.
 
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