Clinical Trials in the USA
Regulatory framework
FDA-regulated device clinical investigations in the USA are governed by:
- 21 CFR Part 812 — IDE regulations
- 21 CFR Part 56 — IRB regulations
- 21 CFR Part 50 — Protection of human subjects / informed consent
- 21 CFR Part 54 — Financial disclosure by clinical investigators
- ICH E6 (R2) — GCP guidelines (adopted by FDA for device trials)
Key requirements
| Requirement | Regulatory basis |
|---|---|
| IDE approval (SR devices) | 21 CFR Part 812 |
| IRB approval (all devices) | 21 CFR Part 56 |
| Informed consent | 21 CFR Part 50 |
| GCP compliance | FDA GCP guidance |
| Financial disclosure | 21 CFR Part 54 |
| ClinicalTrials.gov registration | FDAAA 2007 (mandatory for applicable device trials) |
| Adverse event reporting (during study) | 21 CFR § 812.150 |
ClinicalTrials.gov registration
The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires registration of applicable device clinical trials on ClinicalTrials.gov. Registration must occur within 21 days of enrolling the first participant. Results reporting is also required for applicable trials.
FDA's role during a trial
For IDE-approved studies, FDA may:
- Review the IDE application and amendments
- Inspect the clinical site and IRB
- Request adverse event reports
- Place an IDE on clinical hold if safety concerns arise
- Approve or disapprove protocol changes