Summons of Premarket Approval (PMA)
PMA is the one of the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. It is a substantial requirement for applicant to get an approval for PMA application before starting any marketing activities. Approval of the PMA depends on the provided scientific evidence assuring that the device is safe and effective for the proposed use specified in the application. As per the regulation, it should take 180 days to approve or reject the PMA application, but in reality, it takes longer most of the time. After the applicant submits the PMA, the FDA will send the application to the appropriate advisory committee for review at a public meeting. The committee will provide the recommendation and facts supporting whether to approve or reject the application.
Once the submission is determined by FDA, the applicant will be notified about approval or rejection of their application and FDA publishes a notice on their website with the aims of
- Stating the data on which the decision is based, and
- Rendering interested people an opportunity to petition FDA within 30 days for reconsideration of their decision.
On successful completion of a PMA process, an approval in the form of a private license acknowledging the applicant a permission to market the device is released.