Postmarket Surveillance of Medical Devices

This ICR collects information from manufacturers who are required to conduct postmarket surveillance of a medical device that meets the criteria set forth in the statute. The postmarket surveillance submission includes the postmarket plan, information about the person designated to conduct the surveillance, and organizational/administrative information. The information collection also includes the submission of changes to the plan, requests for a waiver of any requirement of the regulation, requests for exemption from the requirement to conduct postmarket surveillance, and submission of periodic reports as specified in the postmarket surveillance plan. Additionally, manufacturers and investigators must maintain records to ensure that the postmarket surveillance is conducted in accordance with the approved plan. The information collected and maintained enables FDA to ensure that the postmarket surveillance will result in the collection of useful data that can reveal unforeseen adverse events or other information necessary to protect the public health.

The latest form for Postmarket Surveillance of Medical Devices expires 2022-11-30 and can be found here.

Postmarket Surveillance of Medical Devices: submissions, changes, waivers, exemption requests, reports

Federal Enterprise Architecture: Health - Consumer Health and Safety