Compliance Focused Preapproval Preparation Program

Submitting a Premarket Approval Application (PMA) for a Class III medical device to the US Food and Drug Administration (FDA) initiates a cascade of activities that requires the company to be operating at peak performance. Once the PMA is submitted, it is logged and issued to the Division of Bioresearch Monitoring (DBM) for assignment of initial review to determine whether it is fileable.