Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
This guidance document will assist manufacturers of devices subject to section 522 postmarket surveillance orders imposed by FDA.
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:
Division of Dockets Management (HFA- 305)
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-2011-D-0514.