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GUIDANCE DOCUMENT

Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process Guidance for Industry and FDA Staff December 2008

Download the Final Guidance Document
Final
Docket Number:
FDA-2007-D-0025
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health

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

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2007-D-0025.

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