PMA Supplements & Amendments
US-unique
The PMA supplement system is a US-specific mechanism for managing post-approval changes to Class III devices. It has no direct equivalent in other jurisdictions.
When a PMA supplement is required
Any change to an approved PMA that affects safety or effectiveness requires a supplement — not a new PMA. Changes requiring supplements include:
- New indications for use
- Material changes to the device
- New or modified manufacturing methods
- Changes to performance characteristics
- Software changes (significant)
- New clinical data supporting expanded use
Types of PMA supplements
| Supplement type | When used | Review time goal |
|---|---|---|
| 180-day PMA Supplement | Major changes affecting safety/effectiveness | 180 days |
| Real-Time Supplement | Minor modifications with well-established assessment methods | 30–90 days |
| Special PMA Supplement (30-day notice) | Manufacturing changes with established methods and low risk | 30 days (FDA may approve or require supplement) |
| Panel Track Supplement | Major changes requiring panel review | 180 days + panel |
Changes that do NOT require a supplement
Some changes may be made under a 30-day notice (notification to FDA within 30 days of implementing the change):
- Changes using methods previously reviewed by FDA
- Certain manufacturing process changes
- Changes supported by an FDA-recognised standard
Other changes may qualify for documentation only — included in the annual PMA report but requiring no prior FDA notification.
Annual PMA report
Approved PMA holders must submit an Annual Report to FDA summarising:
- Changes made under 30-day notice or documentation
- Complaints and adverse events
- Post-approval study progress
- Current labelling