The US Food and Drug Administration (FDA) has issued draft guidance to help Medical Device Manufacturers comply with postmarket surveillance requirements and to understand the agency’s expectations for post-approval studies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).
Check out this 522 Postmarket Surveillance Studies Database
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This draft guidance document, when finalized, will assist manufacturers of devices subject to section 522 postmarket surveillance orders (522 orders) by providing: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.