Regulatory Open Forum

hello there,

I am currently preparing my first PMA Modular submission for MD, our PMA shell was already accepted, however, after reading "Acceptance and Filing Reviews for PMA Applications", "Premarket Approval Application Modular Review", "Quality System Information for Certain Premarket Application Reviews", "eCopy Program for Medical Device Submissions", and 21CFR814:20, I still have more questions than answers :D

Is there another step-by-step guide for Modular PMA  that I can read to get a better understanding of this process?

Best Regards

Good day Tom,

There is some limited information on the CDRH Learn https://www.fda.gov/training-and-continuing-education/cdrh-learn, but if you have already gone through all the guidance documents, probably not much more from there.  A couple suggestions then, you can ask specific questions here in the Forum though have to use patience because some questions may or may not be answered - plus might not be possible due to confidentiality concerns.  The other suggestion is partner with an expert such as at a consulting company who can assist in the process.  Doing the first one is a bit daunting, though there are always learning from every submission.

hello there,

I am currently preparing my first PMA Modular submission for MD, our PMA shell was already accepted, however, after reading "Acceptance and Filing Reviews for PMA Applications", "Premarket Approval Application Modular Review", "Quality System Information for Certain Premarket Application Reviews", "eCopy Program for Medical Device Submissions", and 21CFR814:20, I still have more questions than answers :D

Is there another step-by-step guide for Modular PMA  that I can read to get a better understanding of this process?

Best Regards