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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 01 July 2011 | By Mike Ronnigen, RAC
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.