Shelf Life Testing of a Sterile Medical Device

M

MIREGMGR

#41
Any recent experience along these lines?
I haven't heard or seen anything similar.

I just submitted two 510(k)s two weeks ago for devices with shelf-life considerations and labeled expiration dates. We've had initial contact with the reviewer for both to discuss another issue, but nothing has been said about the issue you raise.

The change you describe probably could not be made without a Guidance change process, since it would conflict with well understood past practice. No new Guidance has been issued in this area, and I'm not aware of any discussion that one is "in the works".
 
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