PMA

Premarket Approval (PMA) is the FDA's most rigorous type of device marketing application. Required for Class III medical devices that pose the highest risk, PMA is based on a determination by FDA that the device is safe and effective for its intended use.

When PMA is required:
- Class III devices (highest risk)
- Life-sustaining or life-supporting devices
- Devices of substantial importance in preventing impairment
- Devices without a valid predicate for 510(k)

PMA vs 510(k):
| Aspect | PMA | 510(k) |
|--------|-----|--------|
| Risk Class | Class III | Class I, II |
| Standard | Safe & Effective | Substantially Equivalent |
| Clinical Data | Usually required | Rarely required |
| Review Time | 180 days (goal) | 90 days (goal) |
| FDA Decision | Approval | Clearance |

PMA application requirements:
1. Indications for use - Clear intended use statement
2. Device description - Complete technical specifications
3. Manufacturing information - GMP documentation
4. Non-clinical studies - Bench and animal testing
5. Clinical studies - Human clinical trial data
6. Labeling - All proposed labels and IFU

PMA process:
1. Pre-submission meeting (recommended)
2. Submit PMA application
3. FDA acceptance review (45 days)
4. FDA substantive review (180 days goal)
5. Advisory panel meeting (sometimes)
6. FDA decision (approval, approvable, not approvable)

Post-approval requirements:
- Annual reports
- Supplements for changes
- Post-approval studies (if required)
- Adverse event reporting

Timeline: 12-24+ months including clinical trial time. FDA review goal is 180 days, but total process is much longer.