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FDA’s New Draft Guidances on Device Postmarket Surveillance – For Comments

Updated: Aug 21, 2021

The US Food and Drug Administration (FDA) has issued draft guidance to help Medical Device Manufacturers comply with postmarket surveillance requirements and to understand the agency’s expectations for post-approval studies (PASs).


This draft guidance document, when finalized, will assist manufacturers of devices subject to section 522 postmarket surveillance orders (522 orders) by providing:

  • an overview of section 522 of the FD&C Act;

  • information on how to fulfill section 522 obligations, including:

    • - when postmarket surveillance should be considered commenced;

    • recommendations for achieving an approved postmarket surveillance plan in a timely manner; and recommendations for enrollment schedules to help achieve timely completion of postmarket surveillance;

  • recommendations on the format, content, and review of postmarket surveillance plan and report submissions, including revised FDA review times for postmarket surveillance-related submissions; and updated surveillance status categories to better reflect progress

You can submit the comments online for this guidance by 07/26/2021.




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