Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry and Food and Drug Administration Staff; and Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order; Guidance for Industry and Food and Drug Administration Staff; Availability

Resumo

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of the final guidance documents entitled "Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act" and "Procedures for Handling Post-Approval Studies Imposed by PMA [Premarket Approval Application] Order." These guidance documents are intended to facilitate and set expectations for timely initiation and completion of certain studies fulfilling postmarket surveillance requirements and of Post-Approval Studies (PAS), respectively. Additionally, these guidance documents are intended to increase transparency to stakeholders on FDA's approach to the issuance and tracking of postmarket surveillance orders and of PAS requirements. The final guidance "Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act" is intended to update and replace the guidance issued in May 2016; the final guidance "Procedures for Handling Post-Approval Studies Imposed by PMA Order" is intended to update and replace the guidance issued in June 2009.