On May 16, 2016, FDA-CDRH issued a final guidance document entitled Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act.
In the US, FDA may order a manufacturer of certain Class II and Class III devices to initiate a postmarket study. The devices subject to an order are:
- Failure of the device would be reasonably likely to have a serious adverse health consequence
- Expected to have significant use in pediatric populations
- Intended to be implanted in the human body for more than one year
- Intended to be a life-sustaining or life-supporting device used outside of a user facility
The Food, Drug, and Cosmetic Act, FD&CA, provides FDA the authorization in Section 522, so these are usually called 522 orders. The law is implement in the regulations in 21 CFR Part 822. The guidance document provides additional information about the regulation.