PMA Process & Timelines
PMA review milestones
| Step | Timeframe |
|---|---|
| Filing review (accept or refuse to file) | 45 days from receipt |
| Substantive review begins | After filing acceptance |
| Major deficiency letter (if needed) | During review |
| Advisory panel (if convened) | Per panel schedule |
| MDUFA goal — Original PMA | 180 calendar days |
| MDUFA goal — Panel Track Supplement | 180 calendar days |
| MDUFA goal — 180-day Supplement | 180 calendar days |
| MDUFA goal — Real-Time Supplement | 90 calendar days |
Pre-submission strategy
Given the 180-day timeline and high cost of a PMA, pre-submission interaction with FDA is critical:
- Early Q-submission — discuss overall PMA strategy, clinical study design, endpoints
- IDE application — must be approved before beginning pivotal clinical trial
- Pre-PMA meeting — review draft PMA structure and anticipated content
- Pre-approval inspection (PAI) — FDA inspects manufacturing facility before approval
Post-approval conditions
FDA approval of a PMA typically includes conditions of approval:
- Post-approval studies (PAS)
- MDR reporting
- Annual reporting
- Device tracking (for certain implants)
- Patient labelling
Failure to comply with conditions of approval may result in withdrawal of approval.
Official resources
Filing Review (Refuse to File Review)
Within 45 days of submission, FDA conducts a filing review to determine if the PMA is sufficiently complete to permit a substantive review. FDA may:
• Accept the application and begin substantive review • Issue a Refuse to File (RTF) letter if the PMA lacks essential information or does not comply with regulatory requirements
Common reasons for RTF include:
• Missing required sections (e.g., clinical data, manufacturing information) • Inadequate clinical study design or data • Incomplete financial disclosures • Missing or non-compliant environmental assessment
If RTF is issued, the applicant may resubmit after addressing deficiencies.