Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process
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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.