Will you use the FDA's ISO 13485 Voluntary Report Submission Program?

[sshankle]

So now that the guidance is official and the pilot program has started, will you use this program? Care to share why or why not?

I will use it. When you've got a good record, I feel that there is nothing to hide and welcome opportunity for transparency. This is quite situational, of course. If a firm where in the middle of correcting major deficiencies, it might not be the most effective path.

I suspect there is also a timing component. If you had been inspected by FDA in the last few months, participating is of no value to you for at least a year.

Any others care to share their thoughts?

 

[Doug Tropf]

Re: Will you use FDA's ISO 13485 Voluntary Report Submission Program?

We plan to use the program however, I'm discovering the process to get set-up for participation has issues (on the FDA's end).

 

[Dudes]

Re: Will you use FDA's ISO 13485 Voluntary Report Submission Program?

We haven't decided yet, but may use it...

 

[sshankle]

Re: Will you use FDA's ISO 13485 Voluntary Report Submission Program?

We haven't decided yet, but may use it...

Sounds like you are on the fence. Care to share the reasons why, or is it that it hasn't been evaluated yet?

 

[Dudes]

Re: Will you use FDA's ISO 13485 Voluntary Report Submission Program?

Sounds like you are on the fence. Care to share the reasons why, or is it that it hasn't been evaluated yet?

It just hasn't been properly evaluated yet.

 

[Mondo 22]

Why wouldnt you want an FDA Inspection?

 

[phloQS]

We are just trying to enter the US-market and evaluating if we are able to take part in the programm, because we never have had a FDA inspection yet. What are your suggestions? Will they accept it? We have no problems with ouir ISO-inspections and nothing to hide. But taking part would give us the effort of having just one inspection a year without losing menpower for another one.

regards

phloQS

 

[Mondo 22]

by entering the US market, what do you mean? 510(k) or PMA?

If it is a PMA an inspection is mandatory and the scheme can not be used as i understand it.

I would suggest having a mock FDA audit rather than using the scheme.

 

[phloQS]

I mean 510(k). I know that with PMA the scheme can not be used

 

[Mondo 22]

Personally if i was you and you were worried about your compliance to the QSR's, i would have a mock FDA inspection to identify any gaps.

Otherwise, i would just carry on with your applications and if they FDA choose to schedule an audit then you will have a quality system that should be 99% compliant.

Others may disgaree ....