Can one question a 510(k) decision?

LievenDW

Involved In Discussions
#1
If one has reasons to believe a 510(k) is granted unjustfully, is there a formal procedure to make objections, or to question the FDA's decision?
 
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MIREGMGR

#2
Re: Can one question a 510(k) decision

Yes. See www .fda .gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM094523.pdf. - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS
 
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sagai

Quite Involved in Discussions
#3
Re: Can one question a 510(k) decision

I am only wondering how could anybody gain such insider info and what potential legal consequence may occur.
As far as I know FDA releases only the Summary of the 510k clearance to public.
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Sz.
 
M

MIREGMGR

#5
Re: Can one question a 510(k) decision

you may request the whole 510(k) file under Free Information Act. But it will take a long time to get.
Part of the reason why FOIA requests for regulatory action information take so long is that the applicant is notified and given an opportunity to propose any redactions that they can justify as unnecessarily disclosing proprietary information.

The bar is very low on such redactions...the internal FDA guidance, because the FDA is more directly governed by the FDC Act than by the FOI Act, is to lean toward accepting pretty much any such justifications.

In practice, many such 510(k) FOIA requests are a lot of work to pursue, resulting in receipt of not much more than a few odds and ends that don't include the parts that were of interest in the first place.
 

Statistical Steven

Statistician
Staff member
Super Moderator
#6
Adding complexity to the situation is the time lag from when a 510(k) is granted and when it is available via FOI. Truth is, unless you believe a 510(k) infringes on intellectual property you would be hard pressed to get a judgement against the granting of a 510(k).
 
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