FDA Finalizes Guidance on Post-Approval Studies of Devices and Post-Market Surveillance

The U.S. Food and Drug Administration (FDA) released two final guidelines on Oct. 7 to help moderate-to-high-risk medical device manufacturers comply with the agency’s post-market surveillance requirements and better understand the agency’s expectations regarding the conduct of post-approval studies of these products.

The final versions contain minor changes from the preliminary versions published for comment in May 2021. (RELATED: FDA Releases New Draft Guidance on Post-Market Device SurveillanceRegulatory guidance May 28, 2021).

“These guidance documents are intended to facilitate and set expectations for the timely initiation and completion of certain studies meeting the requirements for post-marketing surveillance and post-approval studies (PAS), respectively. , these guidance documents are intended to increase transparency for stakeholders about the FDA’s approach to issuing and tracking postmarketing surveillance orders and PAS requirements,” the FDA said.

The Procedures Guidelines provide recommendations on the format and content of PAS submissions as a condition of pre-market approval (PMA) and are intended to facilitate reviews of these PAS protocols.

The revisions clarify the information that must be submitted in registration reports, interim PAS reports, and final PAS reports. The final document also clarifies how sponsors must make changes to an approved PAS protocol, as well as the use of alternative study designs such as real-world data and revises the definition of PAS status, the FDA said.

The Postmarketing Surveillance Guidelines address the FDA’s interpretation of postmarketing surveillance orders under Section 522 of the Federal Foods, Drugs and Cosmetics (FD&C Act) regarding certain Class II or Class III medical devices.

The revisions clarify what information should be included in postmarketing surveillance plans, as well as listing reports, interim reports and final reports, the FDA said. The final version also clarifies how changes should be made to an approved post-market surveillance plan.

The guidelines are intended to help manufacturers of Class II and Class III devices comply with FDA post-market surveillance orders. Such orders may be requested if the devices meet the following criteria: failure of the device would reasonably be expected to cause serious adverse health consequences; the device is expected to have “significant use” in the pediatric population, the device is intended to be implanted for more than one year; and the device is intended to be life sustaining or life sustaining.

Final FDA Guidance on Post-Approval Study Management Procedures

FDA Final Guidance on Postmarketing Surveillance

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