USA – FDA finalizes guidances on device post-approval studies, postmarket surveillance

The US Food and Drug Administration (FDA) on 7 October released two final guidances to assist manufacturers of moderate- to high-risk medical devices to comply with the agency’s postmarket 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. (RELATED: FDA issues new draft guidances on device postmarket surveillance, Regulatory Focus 28 May 2021).

“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,” 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…