Use of Data from Approved PMAs to Support New Device Approvals After 6 Years
This guidance explains FDA's interpretation of section 216 of FDAMA, which allows FDA to use data from approved PMAs after 6 years for specific regulatory purposes, excluding manufacturing methods and trade secrets. The guidance applies to PMAs approved after November 28, 1990.
What You Need to Know? 👇
What is the six-year rule under Section 216 of FDAMA?
The six-year rule allows FDA to use data from approved PMA applications (excluding manufacturing methods and trade secrets) six years after approval to evaluate other devices, establish standards, or support reclassification decisions.
Which PMA data can FDA access under the six-year provision?
FDA can use clinical and preclinical test data demonstrating safety and effectiveness, plus publicly available Summary of Safety and Effectiveness Data (SSED). Manufacturing methods, product composition, and trade secrets remain protected.
Does the six-year rule allow competitors to see my confidential PMA data?
No. The provision only allows FDA internal use of data for regulatory decisions. It doesn’t authorize disclosure of confidential information to competitors or change existing confidentiality protections for your proprietary data.
How can I reference six-year data in my new PMA application?
You must provide detailed justification showing how earlier SSED data applies to your device, demonstrate device similarities, and explain relevance to your submission. Contact the appropriate ODE review division for guidance.
What PMAs are covered under CDRH’s interpretation of Section 216?
CDRH applies Section 216 only to PMAs approved after November 28, 1990 (SMDA enactment date). Data from PMAs approved before this date cannot be used under this provision.
How will I know if FDA uses my PMA data for another application?
FDA plans to identify the source PMA SSED number in new device SSEDs when six-year data is used. This notification method helps track data usage while maintaining confidentiality protections.
What You Need to Do 👇
Recommended Actions
- Review PMAs approved after November 28, 1990, to identify potentially useful data for your submission
- Prepare detailed justification explaining how previous data applies to your device
- Document device similarities to support use of previous data
- Consult with appropriate FDA review division before using 6-year provision
- Ensure no trade secrets or manufacturing information is included in data usage requests
- Monitor FDA’s use of your PMA data through SSED publications
- Consider using 6-year provision particularly for reclassification, standards development, or guidance document creation
- Maintain clear documentation of which previous PMA data is being referenced in submissions
Key Considerations
Clinical testing
- Clinical test data from approved PMAs can be used after 6 years to support other device approvals
- Data must demonstrate safety and effectiveness of the device
Non-clinical testing
- Preclinical test data from approved PMAs can be used after 6 years to support other device approvals
- Data must demonstrate safety and effectiveness of the device
Safety
- Safety data from approved PMAs can be used after 6 years for:
- Approving another device
- Determining completion of product development protocols
- Establishing performance standards or special controls
- Device classification or reclassification
Other considerations
- Manufacturing methods and trade secrets are excluded from the 6-year data use provision
- Applicants must provide detailed justification of how previous data applies to their device
- Data confidentiality is maintained - the provision does not authorize FDA to disclose data to competitors
- FDA will identify in the SSED when data from previous PMAs are used
Relevant Guidances 🔗
- Post-Approval Studies for Medical Devices: Protocol Development, Tracking and Reporting Requirements
- Real-Time Review Process for Minor Changes to Approved Medical Devices through PMA Supplements
- Manufacturing Site Inspections and PMA Review Process for Medical Devices
- Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
- Annual Reports for PMA-Approved Medical Devices: Content, Format and Submission Requirements
Related references and norms 📂
- 21 CFR 20.61: Definition of trade secrets