- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter 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.
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:
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.