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.
Recommended Actions
- Ensure all PMA submissions include valid eCopy/eSTAR and user fees where applicable
- Plan submission timelines considering:
- 15-day acceptance review
- 45-day filing review
- 90-day Substantive Interaction goal
- MDUFA decision timelines based on submission type
- Prepare for potential FDA actions:
- Approval Order
- Approvable Letter
- Major Deficiency Letter
- Not Approvable Letter
- Denial Order
- 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
- Monitor submission status against MDUFA goals and be prepared for additional interactions if goals are missed
- Consider withdrawal implications if unable to respond within 360 days to certain FDA actions
Key Considerations
Other considerations
- All PMA submissions require a valid eCopy or eSubmission (eSTAR when available)
- Most PMA submissions are subject to user fees
- Original PMAs and panel-track supplements undergo acceptance review (15 days) followed by filing review (45 days)
- Substantive Interaction goal of 90 FDA days for 95% of submissions
- MDUFA decision goals:
- 180 FDA days for original PMAs/panel-track supplements without panel (90%)
- 320 FDA days for original PMAs/panel-track supplements with panel (90%)
- 180 FDA days for 180-day supplements (95%)
- 90 FDA days for real-time supplements (95%)
- Total Time to Decision goals:
- FY2023-2024: 290 calendar days average
- FY2025-2027: 285 calendar days average
- FDA will provide Missed MDUFA Decision communication if decision exceeds goal by 20 days
Relevant Guidances
- Electronic Copy (eCopy) Program for Medical Device Submissions: Technical Standards and Requirements
- Electronic Submission Template And Resource (eSTAR) for De Novo Classification Requests
- Quality System Information Requirements for Premarket Submissions
- Real-Time Review Process for Minor Changes to Approved Medical Devices through PMA Supplements
- Manufacturing Site Inspections and PMA Review Process for Medical Devices
- User Fees and Refunds for Premarket Approval Applications and Biologics License Applications
Related references and norms
- 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.