PMA Overview — When PMA is Required
What is PMA?
Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. Under 21 CFR Part 814 and FD&C Act § 515, PMA requires the applicant to demonstrate reasonable assurance that the device is safe and effective through valid scientific evidence.
Unlike 510(k), PMA is not a comparative standard — it requires affirmative proof of safety and effectiveness, typically including clinical data from well-controlled clinical investigations.
When is PMA required?
PMA is required for Class III devices — devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.
Examples of Class III devices requiring PMA:
- Implantable cardiac pacemakers and defibrillators
- Left ventricular assist devices (LVADs)
- Deep brain stimulators
- Total artificial hearts
- Breast implants
- High-risk surgical implants (e.g., certain spinal devices)
- Some neurovascular devices
PMA vs 510(k) — key differences
| Aspect | PMA | 510(k) |
|---|---|---|
| Standard | Valid scientific evidence of S&E | Substantial equivalence to predicate |
| Clinical data | Usually required (IDE study) | Not always required |
| FDA decision | Approval | Clearance |
| Changes | PMA supplement required | New 510(k) or Special 510(k) |
| Fee (FY2026) | ~$430,000 | ~$23,000 |
| Timeline goal | 180 days (standard) | 90 days |