MDR Rules Change Revealed in Warning Letter

Stijloor

Staff member
Super Moderator
#11
Just came across this old thread, since I'm deep in the process of reading guidance documents and regulations to prepare updated MDR/recall SOPs for our company. I thought I'd point out for anyone else who happens upon this thread that the new US MDR draft guidance issued July 9, 2013 does formally rescind the 2 year assumption – you now need to request an exemption if you want to avoid reporting additional malfunctions of the same type, regardless of the timeframe in which no injuries have occurred.

Sorry, can't post links to the updated guidance since I don't have enough posts. :(
Write the link without the W's and the .com and one of our Moderators should be able to activate.
 
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MIREGMGR

#12

Jen C

Involved In Discussions
#13
That is, it will rescind, upon eventual finalization, if not revised in the meantime. Based on past history, final issuance occurs one to two years after issuance of a draft...though there have been a couple of drafts that never have been finalized.
Yes, of course ? and thanks for posting the link! But at the same time, I think the "2 year rule" was only ever in guidance, correct? (I am new to devices, so I'm not 100% sure.) Since the general purpose of guidance is to communicate FDA's current thinking, it seems that this new draft guidance is telling us the 2 year rule is no longer part of their current thinking. In combination with the warning letter mentioned at the beginning of this thread, I think that's a pretty good indication that a company shouldn't assume the 2 year rule is still valid.
 
M

MIREGMGR

#14
I think the "2 year rule" was only ever in guidance, correct?
Yes, but most FDA direction only exists in written form as a "guidance". That term has a rather more obligatory functional definition at FDA. :)

(...) I think that's a pretty good indication that a company shouldn't assume the 2 year rule is still valid.
The word "assume" of course is ever problematic. If I can't operate on definitive information, I usually try to determine in which direction it could cause me more trouble, and not assume in that direction.

In this case, one might want to either assume that the two year rule still is valid, or ask FDA by email for an explanation of their right-now enforcement view so that you (eventually) have their response in writing. Assuming in the other direction could expose you to a Warning Letter such as that discussed earlier, if your assumption was wrong.

In that regard, Wes's comments above about FDA sectional "mission creep" are germane. "Mission creep" is a current problem with 510(k) reviewers in ODE, relative to their implementation of requirements well beyond those in current 510(k) guidances.
 
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