Vicki, could you clarify what your "start" and "finish" points will be?
The simplest starting point is the point at which all of the documents that need to be included in the PMA have been completed, reviewed, and approved. The simplest ending point is the point at which you submit the PMA. The process in-between is fairly straightforward to train on. If you work in a regulatory department based on what one regulatory professional described to me long ago as "the shoebox model" of regulatory affairs...people bring you a bunch of documents, you put them in a shoebox and give them to FDA...then that may be all you need to know, plus how to put together the response to a deficiency letter. That part is fairly easy to train people to do.
Alternatively, if you are a regulatory professional assigned to a product development team, your starting point is the same as theirs--the development of user requirements. You then proceed with the team through the design control process, which is essentially the process by which (almost all of) the documents that need to be included in the PMA are generated. For this part, you would probably have better luck looking for training in the design control process, rather than PMA training.
You may also find separate training on how to manage an FDA panel meeting, which FDA uses far more often when reviewing novel devices than "me toos."
At some point, you are not looking for training on "how to do a PMA," but "how to develop and market a Class III device," which is pretty much what you need, if you are going to step outside the shoebox. I know of no such training; maybe someone else does. The industry is generally so averse to Class III and it takes so long to go through the entire process (and experience with one Class III device would not provide a sufficient basis for a "OSFA" training program), that there may not be enough experience out there to develop this type of training, nor enough people to take it, for anyone to invest the significant amount of time that would be needed.
Be warned that a PMA is not just a big 510(k). It's based on a very different model and mindset (scientific rather than engineering).
Because there is no predicate, there is no neatly laid out path to market and beyond. The product development team will have to figure out what is required to demonstrate the device's safety and effectiveness, and then present a compelling argument to the FDA as to why what they have done is, in fact, adequate to demonstrate safety and effectiveness. One of the key roles of the regulatory professional assigned to a PMA project (not just to "do the submission) is to help the team develop arguments that the FDA is likely to find compelling.
Nor is there any real "finish" to a PMA as long as the product is being sold in the US. For this reason, you will probably not find training that is truly "start to finish" for a PMA. Most first PMAs are trial by fire, especially if you don't report to a more experienced regulatory professional who has already been through the fire themselves.
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Julie Omohundro RAC
Durham NC
United States
Original Message:
Sent: 01-15-2016 12:09
From: Vicki Gail
Subject: PMA specific education
Thank you all for the suggestions. The PMA is an existing filing with the FDA and I will be assuming the responsibilities. My experience is with FDA Class I and Class II (510k) devices/filings. I am looking to learn the "start to finish" actions for a PMA in order to continue with the existing filing and possible a new filing.
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Vicki Gail
QA / RA Manager
Agoura Hills CA
United States