Modifications to Devices Subject to Premarket Approval (PMA) – The PMA Supplement Decision-Making Process: Guidance for Industry and FDA Staff

Issue Date: December 11, 2008
Issued by: Center for Biologics Evaluation and Research
Topic(s): Premarket, Premarket Approval (PMA)
Status: Final

Modifications to Devices Subject to Premarket Approval (PMA) – The PMA Supplement Decision-Making Process: Guidance for Industry and FDA Staff

This guidance document has been developed to provide the underlying principles and examples to establish a clear and consistent way to approach the decision-making process you follow to determine the type of regulatory submission, if any, that may be required when you modify your lawfully marketed PMA device.

Download the Guidance Document