Premarket Approval of Medical Devices

This ICR collects information from persons filing a PMA application or a PMA supplement with FDA for approval of certain class III medical devices. The PMA regulation establishes procedures that FDA utilizes in approving, denying, or withdrawing approval of any PMA. It provides specific, clear, and flexible instructions to applicants so those respondents know what information is required in a PMA. PMA supplements are also used by FDA to determine any additional action the agency must take to protect the public health. The data reported to FDA and the records that are maintained allow FDA and industry to make decisions and take actions to protect the public health from defective medical devices.

The latest form for Premarket Approval of Medical Devices expires 2023-03-31 and can be found here.

Premarket Approval of Medical Devices Reporting Requirements

Federal Enterprise Architecture: Health - Consumer Health and Safety