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USFDA MD Guidance: Postmarket Surveillance & Procedures for Handling Post-Approval Studies

USFDA's Center for Devices and Radiological Health released two updated, finalized guidelines yesterday and earlier today (07-October-2022) related to Postmarket Surveillance and Procedures for Handling Post-Approval Studies (PAS) Imposed by Pre Market Approval applications (PMA) Orders.

1. Guidance on Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act

Postmarket surveillance is the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device.

The FDA is empowered by this guidance, which ensures manufacturers conduct postmarket surveillance at the time of approval or clearance or at any time thereafter for certain class II and class III devices. In addition, this document provides stakeholders with greater transparency about FDA's approach to issuing and tracking 522 orders, as well as expectations for the study to be completed in a timely manner.

2. Guidance on Procedures for Handling Post-Approval Studies Imposed by PMA Order

A Post-Approval Study is usually a clinical or non-clinical study, as specified in the PMA approval order, and is typically intended to gather specific data to address questions about the postmarket performance of or experience with an approved medical device.

FDA evaluates premarket approval applications in a multi-step process to determine whether reasonable assurance of device safety and effectiveness has been demonstrated.

This guidance provides the details for the stakeholders regarding the requirements for post-approval studies (PAS) as a condition of PMA approval.

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