Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry and Food and Drug Administration Staff; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled "Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act." This guidance is intended to assist manufacturers of devices subject to section 522 postmarket surveillance orders by providing an overview of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), information on how to fulfill section 522 obligations, and recommendations on the format, content, and review of postmarket surveillance plan submissions.