FDA Voluntary Audit Report Submission Pilot Program now a final guidance document

G

Gert Sorensen

#1
FDA has just release this guidance document:

Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program

That may have a major impact on the european device industry.

Anybody care to wager a guess as to how it will affect us?

:bigwave:
 

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M

MIREGMGR

#2
Re: Voluntary Audit Report Submission Pilot Program, now a final guidance document

A year or so ago, they asked for volunteers for a trial program, and I sent in the requested submission. Supposedly they were going to start up the trial evaluations by last June, with the full scale program beginning last December. To my knowledge nothing has happened yet, and I haven't had any response or feedback regarding our submission.

I'm not aware of significant effects that VARSP might have that would be different for European than US device makers. Of course, the fundamental concept is that if you're already being audited to ISO 13485 by an NB authorized under a GHTF-founding-country regulatory system and can show the required evidence of conformity and no problems, US FDA will take you off the QSIT1 inspection rotation for the forthcoming year. If enough companies did so after an eventual broad rollout, FDA could devote their entire inspection resources to the companies that aren't participating, and more of their inspections would be done at manufacturers that need oversight.

Presumably almost all European device makers that market in the US would be eligible for VARSP if their audits were clean, but of course lots of US device makers that market in the EU would have the same eligibility.

Two prior threads in which I discussed our volunteering for the trial program, which I originally was told would be called VASP:
Rate your FDA Audit Experience
ISO 13485 IAF Medical Device Conformity Assessment System IAF-MDCAS
 
P

phloQS

#4
Re: Voluntary Audit Report Submission Pilot Program, now a final guidance document

Hi everybody,

My company is just starting to enter the US-Market. We already finished our 510Ks. We are a german company and just finished our last surveillance audit. So does anybody think it would be a good idea to take part in the volunteer program?
Any suggestions would be great
Regards

phloQS
 
M

MIREGMGR

#5
Re: Voluntary Audit Report Submission Pilot Program, now a final guidance document

If you participate and everything goes smoothly, you eliminate your exposure to an FDA QSIT-1 (random surveillance) inspection.

Hypothetically, if everything doesn't go smoothly, it could have some visibility-repercussions...though FDA hasn't talked about any mechanisms to accomplish such monitoring of the process.
 
G

Gert Sorensen

#6
Re: Voluntary Audit Report Submission Pilot Program, now a final guidance document

I think that you may find this very beneficial to participate in, provided that your company can supply the needed number of audit reports, and a current report in the accepted format. It would be a good signal to send to the FDA that you do take compliance seriously, and is willing to participate in a program which main purpose is to let FDA direct its ressources to more "needy customers". It will also provide you with an added leverage in your organization because every future ISO audit will be more important when it has to be submitted to the FDA too.
:)
 
M

MIREGMGR

#7
Re: Voluntary Audit Report Submission Pilot Program, now a final guidance document

Today we received our Voluntary Audit Report Submission Program (VARSP) notification that we have been accepted, and removed from the "routine work-load plan" for QSIT 1/2 surveillance inspections. We of course still could be subject to for-cause or PMA-related inspections, and so forth.

Interestingly, this removal is for one year from the date of the last day of the most recent ISO 13485 inspection. Since it took us nearly the full allowed 90 days to obtain our final audit report from our NB and get our application submitted to FDA in acceptable electronic form, and then exactly the allowed 30 days for FDA to make its determination, we are only excused from surveillance audit for about eight months from today.

This can be renewed annually, assuming that the applicant newly meets the relevant criteria each year. It appears however from this timing structure that there will be a gap of at least a month and a half between successive excused-periods, since the irreducible minimum time for a final audit report seems to be about two weeks and the FDA thirty day decision period is fixed.
 
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