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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.

  1. Review PMAs approved after November 28, 1990, to identify potentially useful data for your submission
  2. Prepare detailed justification explaining how previous data applies to your device
  3. Document device similarities to support use of previous data
  4. Consult with appropriate FDA review division before using 6-year provision
  5. Ensure no trade secrets or manufacturing information is included in data usage requests
  6. Monitor FDA’s use of your PMA data through SSED publications
  7. Consider using 6-year provision particularly for reclassification, standards development, or guidance document creation
  8. 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

  • 21 CFR 20.61: Definition of trade secrets

Original guidance

  • Use of Data from Approved PMAs to Support New Device Approvals After 6 Years
  • HTML / PDF
  • Issue date: 2000-08-08
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices
  • ReguVirta summary file ID: 73e1987f2817ef3d3c32a2b087987d95
This post is licensed under CC BY 4.0 by the author.