FDA makes minor updates to the Refuse to Accept Policy for 510(k)s final guidance

U.S. Food and Drug Administration sent this bulletin at 04/21/2022 01:20 PM EDT

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FDA - Center for Devices and Radiological Health

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Minor Updates to Refuse to Accept Policy for 510(k)s Final Guidance

See Guidance

Today, the U.S. Food and Drug Administration (FDA) updated the 2019 final guidance: Refuse to Accept Policy for 510(k)s. The minor updates and clarifications include: 

  • Correction of broken links  
  • Providing additional clarity that devices ineligible for 510(k) (for example, a device type classified in class III requiring PMA) may be refused by the FDA

The acceptance checklists were not substantively changed in this update.

Questions?

If you have questions about these updates, contact the Division of Industry and Consumer Education.