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