FDA Announced Draft Guidance: The Special 510(k) Program


Key Takeaways:

  • The Special 510(k) Program is an alternate pathway for premarket notifications.

    • It was originally established in 1998.

    • It allows manufacturers to declare that a modification to their own device cleared under 510(k) still conforms to design controls.

  • Currently, if a manufacturer modifies its own marketed device and changes the indication for use or creates technological differences, the application must be submitted as a traditional 510(k).

  • The draft guidance proposes:

    • to expand when the Special 510(k) Program may be used.

    • to clarify which types of technological changes and labeling changes may qualify under the expanded Special 510(k) Program.

  • Additionally, when finalized, the draft guidance:

    • could streamline review and reduce regulatory burdens.

    • will replace the Special 510(k) policy from the current guidance, The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.

The comment period for the draft guidance is open through November 27, 2018. Comments can be submitted here, and the draft guidance can be found here.


- The Clinical Pathways Team 

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