The US Food and Drug Administration (FDA) on 7 October 2022 released two final guidances to assist manufacturers of moderate- to high-risk medical devices to comply with the Agency’s post-market surveillance requirements and to better understand the Agency’s expectations for conducting post-approval studies of these products. The final versions contain minor changes from the draft versions released for comment in May 2021.
“These guidance documents are intended to facilitate and set expectations for timely initiation and completion of certain studies fulfilling post-market 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 post-market surveillance orders and of PAS requirements,” FDA said.
The procedures guidance provides recommendations on the format and content of PAS submissions as a condition of premarket approval (PMA) and is intended to help facilitate reviews of these PAS protocols. Revisions clarify the information that should be submitted in enrollment reports, interim PAS reports and final PAS reports. The final document also clarifies how changes to an approved PAS protocol should be made by sponsors as well as clarify the use of alternative study designs such as real-world data and revises the definition of PAS status, said FDA.
The post-market surveillance guidance addresses FDA’s interpretation of post-market surveillance orders under section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) with respect to certain Class II or Class III medical devices.
The revisions clarify the information that should be included in post-market surveillance plans, as well as enrollment reports, interim reports and final reports, said FDA. The final version also clarifies how changes to an approved post market surveillance plan should be made.
The guidance aims to help manufacturers of Class II and Class III devices comply with FDA’s post-market surveillance orders. Such orders may be requested if devices meet the following criteria:
- a failure of the device would be reasonably likely to have a serious adverse health consequence;
- 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-supporting.
REFERENCE: RAPS Regulatory Focus/Regulatory News;10 OCT 2022; Joanne S. Eglovitch