Responsibilities of Individual named as Submitter of 510(k)

P

Paul_D

#1
Does anyone have a summary of the responsibilities (and possible consequences!) of being the named submitter on a 510k?

Thanks
 
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M

MIREGMGR

#2
The legal responsibilities and consequences attach to the company for which the filer is an agent. If the FDA determined that a submission was fraudulent, hypothetically they could bring an action against the company and individual for false attestation to an official document, or somesuch. I don't know the specific legal context, but I'm sure there's a relevant law in that regard.
 
P

Paul_D

#4
I guess a more accurate question would have been the responsibilities that go with being the individual named on the "Truthful and Accuracy Statement" section of the 510(k).
This is being asked in the context of an organization who is looking to become a medical devices company who isn't currently, i.e. to explain the importance and consequence of what goes with the position of being the 510(k) "owner"
 

Ronen E

Problem Solver
Staff member
Moderator
#5
I guess a more accurate question would have been the responsibilities that go with being the individual named on the "Truthful and Accuracy Statement" section of the 510(k).
This is being asked in the context of an organization who is looking to become a medical devices company who isn't currently, i.e. to explain the importance and consequence of what goes with the position of being the 510(k) "owner"
Hi & welcome to the cove :bigwave:

I guess from a legal standpoint this is no different to any other false declaration. I don't think the medical device context really matters a lot in this case.

Typically the individual signing this statement would be senior enough in the organization to realize the meaning of signing a false declaration (or just be negligent or careless with regards to it). Even if they are not currently in the medical devices business.

Cheers,
Ronen.
 
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