Certifying Compliance with Clinical Trial Registration Requirements on Form FDA 3674
This guidance clarifies FDA's requirements regarding Form FDA 3674 certifications that must accompany certain drug, biological product, and device applications/submissions. The certification confirms compliance with clinical trial registration and results reporting requirements under Title VIII of FDAAA.
What You Need to Know? 👇
What is Form FDA 3674 and when is it required for medical device submissions?
Form FDA 3674 is a certification form required to accompany certain FDA applications and submissions, confirming compliance with clinical trial registration and reporting requirements under Title VIII of FDAAA. It’s required for PMAs, PMA panel track supplements, HDEs, and 510(k)s that include clinical trial information.
Do I need to submit Form FDA 3674 with every 510(k) submission?
No, FDA exercises enforcement discretion for 510(k) submissions that don’t refer to, relate to, or include information from clinical trials. Only 510(k)s containing clinical trial information require Form FDA 3674 certification to ensure compliance with clinical trial registration requirements.
What happens if I submit a false certification on Form FDA 3674?
Submitting a false certification is a prohibited act under section 301(jj) of the FD&C Act. This can result in enforcement actions by FDA. The certification requirement helps ensure compliance with clinical trial registration and reporting obligations under Title VIII of FDAAA.
Are IND amendments required to include Form FDA 3674 certifications?
Generally no, except for new clinical protocols submitted to existing INDs. Other IND amendments don’t require certifications since they’re analogous to NDA/BLA amendments. New protocols are considered the investigational equivalent of efficacy supplements and therefore require Form FDA 3674.
Does Form FDA 3674 need to include NCT numbers from ClinicalTrials.gov?
Yes, where available, the certification should include appropriate National Clinical Trial (NCT) control numbers. These numbers help FDA link regulatory actions to specific clinical trials in the registry, enabling better public access to trial information and regulatory decisions.
What types of device supplements require Form FDA 3674 certification?
Only PMA panel track supplements require Form FDA 3674. FDA exercises enforcement discretion for other PMA supplements since they typically don’t involve new clinical trials or reference trials already covered by previous certifications, making additional certification repetitive and unnecessary.
What You Need to Do 👇
Recommended Actions
- Implement process to submit Form FDA 3674 with:
- INDs and new clinical protocols
- NDAs and efficacy supplements
- BLAs and efficacy supplements
- ANDAs
- PMAs and panel track supplements
- HDEs
- 510(k)s referencing clinical trials
- Ensure Form FDA 3674 includes:
- Appropriate NCT numbers when available
- Accurate certification of compliance
- Establish tracking system for:
- Clinical trial registration status
- Results reporting compliance
- NCT number documentation
- Train regulatory staff on:
- When certification is required
- How to complete Form FDA 3674
- Enforcement discretion categories
- Implement quality check to verify certification requirements before submission
Key Considerations
Clinical testing
- Certification required for applications/submissions containing clinical trial information
- Applicable to clinical trials that must be registered on ClinicalTrials.gov
- New clinical protocols submitted to an IND require certification
Other considerations
- Form FDA 3674 must include NCT numbers when available
- Failure to submit certification or submitting false certification is prohibited
- FDA will exercise enforcement discretion for:
- Non-efficacy supplements to approved NDAs, BLAs, PMAs
- Supplements to approved ANDAs
- INDs under section 561 of FD&C Act
- 510(k)s not containing clinical trial information
Relevant Guidances 🔗
- Civil Money Penalties Related to ClinicalTrials.gov Requirements
- Electronic Copy (eCopy) Program for Medical Device Submissions: Technical Standards and Requirements
- Electronic Submission Requirements for Medical Device Submissions
Related references and norms 📂
- 21 CFR 50.25(c): Requirements for informed consent documents
- 42 CFR part 11: Clinical trials registration and results information submission
- 21 CFR 312.3: IND definitions
- 21 CFR 312.30(a): Protocol amendments