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.
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
Original guidance
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