Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act." The existing postmarket surveillance guidance was issued in May 2016 to address certain postmarket surveillance requirements. This draft guidance is intended to update the 2016 guidance to increase transparency to stakeholders on FDA's approach to the issuance and tracking of these postmarket surveillance orders, and expectations for timely study completion. This draft guidance is not final nor is it in effect at this time.