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MDUFA Performance Goals and Processing of 510k Submissions

This guidance describes FDA actions and industry actions that may be taken on premarket notifications (510(k)s), and their effects on review goals under MDUFA IV (FY 2018-2022) and MDUFA V (FY 2023-2027). It outlines the review process, timelines, and performance goals for 510(k) submissions.

  1. Ensure payment of appropriate user fees before submission
  2. Prepare complete eCopy or eSTAR submission package
  3. Monitor review timelines and be prepared for:
    • Acceptance Review response within 15 days
    • Substantive Interaction around 60 days
    • MDUFA decision target of 90 FDA days
  4. Plan to respond to any Additional Information requests within 180 calendar days
  5. Maintain active communication with FDA during Interactive Review process
  6. Track submission status against MDUFA performance goals
  7. Be prepared for potential Missed MDUFA Decision communication if review exceeds 100 FDA days
  8. Consider withdrawal strategy if unable to meet response timelines

Key Considerations

Software

  • eSTAR submissions are not subject to Refuse to Accept (RTA) process but undergo technical screening within 15 calendar days
  • All 510(k) submissions need a valid eCopy or electronic submission to initiate review

Other considerations

  • 21 CFR 807: Electronic Code of Federal Regulations - Establishment Registration And Device Listing For Manufacturers And Initial Importers Of Devices

Original guidance

  • MDUFA Performance Goals and Processing of 510k Submissions
  • HTML / PDF
  • Issue date: 2022-10-03
  • Last changed date: 2022-10-03
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Premarket, Biologics
  • ReguVirta summary file ID: 45f66a42af1f6ace3dae4e1dd9c19e49
This post is licensed under CC BY 4.0 by the author.