FDA In Brief: FDA Announces Draft Guidances to Help Increase Transparency, Assist Reporting and Timely Completion for Certain Medical Device Studies After FDA Approval or Clearance

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June 2, 2021 | Originally published by Food and Drug Adminstration on May 26, 2021

The following quote is attributed to William Maisel, M.D., chief medical officer and director of the Office of Product Evaluation and Quality in FDA’s Center for Devices and Radiological Health:

“Today, the FDA issued two draft guidance documents regarding the continuous surveillance of certain FDA approved and cleared devices. When final, these guidance documents will help increase transparency and assist reporting and timely completion of studies on the safety and effectiveness of certain devices.

Even after a device receives FDA clearance or approval to be marketed, our regulatory role continues. We receive and review additional data on certain devices to inform our oversight for the safe and effective use of a device throughout the device lifecycle. These draft guidance documents describing postmarket surveillance of moderate and high-risk devices and post-approval study procedures provide clarity that will help manufacturers better understand the FDA’s requirements and expectations for ongoing data collection for certain approved or cleared devices, which we believe will help increase reporting compliance.

The FDA will continue to reinforce to device sponsors the importance of engaging early and often with the agency to ensure data are properly collected and that all required postmarket studies are properly implemented. Our commitment is to protect the public health by ensuring that devices on the market continue to be safe and effective. FDA’s review of data from post-approval studies and postmarket surveillance is an important part of that commitment.”

Additional Information

  • Today, the U.S. Food and Drug Administration issued two guidances regarding the surveillance of certain medical devices.
  • The first guidance on postmarket surveillance guidance will assist manufacturers of devices subject to an order under section 522 of the Federal Food, Drug, and Cosmetic Act, which authorizes the FDA to require postmarket surveillance (522 order) at any time in the lifecycle of certain Class II (moderate risk) and III (high risk) devices that meet any of the following criteria: a failure with the device would be reasonably likely to have a serious adverse health consequence; the device is expected to be used significantly in pediatric populations; the device is intended to be implanted in the human body for more than one year or a device that is intended to be life-sustaining, or life-supporting and used outside of a device user facility.
  • The postmarket surveillance guidance includes information to assist manufacturers with completing their postmarket surveillance plan according to the 522 order in a timely manner and FDA’s policy of posting information about postmarket surveillance in the 522 Postmarket Surveillance Program Database.
  • The second guidance is an updated post-approval study guidance that will assist stakeholders with understanding post-approval study requirements imposed as a condition of PMA approval by providing procedural information, recommendations concerning post-approval related submissions and others.
  • Post-approval studies may be required as a condition of approval for a premarket approval application and are typically intended to gather specific data to address questions about the postmarket performance of or experience with an approved medical device. As described in Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval Guidance, the FDA may also consider applying such postmarket controls as a way to reduce premarket data collection, when appropriate, to improve patient access to safe and effective medical devices that are important for public health.

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