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FDA Actions on Premarket Approval Applications (PMAs) and Effects on MDUFA Review Goals and Timelines

This guidance describes the different FDA actions and industry actions that may be taken on premarket approval applications (PMAs), as well as their effects on MDUFA IV (FY 2018-2022) and MDUFA V (FY 2023-2027) review goals and timelines. It covers original PMAs, panel-track supplements, 180-day supplements, and real-time supplements.

  1. Ensure all PMA submissions include valid eCopy/eSTAR and user fees where applicable
  2. Plan submission timelines considering:
    • 15-day acceptance review
    • 45-day filing review
    • 90-day Substantive Interaction goal
    • MDUFA decision timelines based on submission type
  3. Prepare for potential FDA actions:
    • Approval Order
    • Approvable Letter
    • Major Deficiency Letter
    • Not Approvable Letter
    • Denial Order
  4. Have processes in place to:
    • Respond to FDA communications within required timeframes
    • Track review clock status
    • Submit amendments appropriately (major vs minor)
    • Handle interactive review requests efficiently
  5. Monitor submission status against MDUFA goals and be prepared for additional interactions if goals are missed
  6. Consider withdrawal implications if unable to respond within 360 days to certain FDA actions

Key Considerations

Other considerations

  • 21 CFR Part 814: Premarket Approval of Medical Devices
  • 21 CFR Part 820: Quality System Regulation

Original guidance

  • FDA Actions on Premarket Approval Applications (PMAs) and Effects on MDUFA Review Goals and Timelines
  • HTML / PDF
  • Issue date: 2022-10-03
  • Last changed date: 2022-10-06
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, Premarket Approval (PMA), Biologics
  • ReguVirta summary file ID: a8c671efb630be436d86816d375b5071
This post is licensed under CC BY 4.0 by the author.