FDA Requirements - Class 1 Exempt Medical Device Recall

We are restructuring our Class 1/exempt Medical Device Recall Procedure. Some of our products do not fall within FDA regulations as they are used for in vitro environmental testing or are for research use only (yes, they are labeled as such). The current process is very vague. Does anyone have suggestions/examples of recall procedures for these types of medical devices?

Gracious thanks!

A Quick Bump!

Can someone help??

Thank you very much!!

TempusVernumProcella said:

Does anyone have suggestions/examples of recall procedures for these types of medical devices?

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I can't offer anything specific to your product types. I would point out though that there don't seem to be any exceptions in the general FDA regulations for particular product types.

The relevant guidance for all FDA regulated products is http://www.fda.gov/medicaldevices/d...nts/recallscorrectionsandremovals/default.htm.