Regulatory Open Forum

Can someone educate me on the number of deficiencies a company (sponsor) can get once they submit the original PMA? For 510k, there is only one round of deficiency (additional information) for which the company gets 180 days to respond but could not find any guidance or regulation which talks about the number of deficiencies for PMA?

If a company fails to answer/address the deficiency within the 180-days, does this mean that FDA grants a PMA disapproval? If they grant a disapproval and the sponsor/company addresses the concerns, does this mean that one has to re-submit all the modules of the PMA or only submit the new information and refile the PMA and the 180-day clock starts from there?

Hello Anon,

There is also only "one" round for responding to deficiencies with a Pre-Market Approval (PMA) for the US FDA, but there are other mechanisms involved with a PMA submission.  There typically is a lot of correspondence and meetings leading up to and through a PMA submission, i.e. 100-day meeting, so usually the deficiency list is or should be well-understood by that point.  And if using a Modular PMA process, it is also a different methodology.  You address the deficiencies with each Module as you progress through the process.

Can someone educate me on the number of deficiencies a company (sponsor) can get once they submit the original PMA? For 510k, there is only one round of deficiency (additional information) for which the company gets 180 days to respond but could not find any guidance or regulation which talks about the number of deficiencies for PMA?

If a company fails to answer/address the deficiency within the 180-days, does this mean that FDA grants a PMA disapproval? If they grant a disapproval and the sponsor/company addresses the concerns, does this mean that one has to re-submit all the modules of the PMA or only submit the new information and refile the PMA and the 180-day clock starts from there?

Thanks Richard. Any insights on the 2nd part of the question?

If a company fails to answer/address the deficiency within the 180-days once the PMA is filed, does this mean that FDA grants a PMA disapproval? If they grant a disapproval and the sponsor/company addresses the concerns, does this mean that one has to re-submit all the modules of the PMA or only submit the new information and refile the PMA and the 180-day clock starts from there?

Hello Anon,

There is also only "one" round for responding to deficiencies with a Pre-Market Approval (PMA) for the US FDA, but there are other mechanisms involved with a PMA submission.  There typically is a lot of correspondence and meetings leading up to and through a PMA submission, i.e. 100-day meeting, so usually the deficiency list is or should be well-understood by that point.  And if using a Modular PMA process, it is also a different methodology.  You address the deficiencies with each Module as you progress through the process.

Can someone educate me on the number of deficiencies a company (sponsor) can get once they submit the original PMA? For 510k, there is only one round of deficiency (additional information) for which the company gets 180 days to respond but could not find any guidance or regulation which talks about the number of deficiencies for PMA?

If a company fails to answer/address the deficiency within the 180-days, does this mean that FDA grants a PMA disapproval? If they grant a disapproval and the sponsor/company addresses the concerns, does this mean that one has to re-submit all the modules of the PMA or only submit the new information and refile the PMA and the 180-day clock starts from there?