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Device Master Files - Content, Format, and Submission Requirements

This guidance outlines the device master file (MAF) system established by FDA to help preserve trade secrets of the ancillary medical device industry while facilitating scientific evaluation of medical devices. It specifically applies to MAFs submitted to the Center for Devices and Radiological Health (CDRH) in support of PMAs, IDEs, or other device submissions.

  1. Determine if information qualifies for MAF submission (trade secret/confidential nature)
  2. Prepare documentation following format requirements (two copies, proper binding, pagination)
  3. Include comprehensive cover letter with required information
  4. Establish process for managing authorizations to clients
  5. Implement system for tracking and submitting amendments
  6. For foreign companies, designate U.S. agent/representative
  7. Clearly mark confidential/trade secret information
  8. Establish procedure for notifying clients of changes
  9. Ensure GMP compliance where applicable
  10. Maintain all documentation in English or provide translations

Key Considerations

Clinical testing

  • Clinical study data can be submitted as a type of MAF

Non-clinical testing

  • Non-clinical study data can be submitted as a type of MAF

Safety

  • Information must be substantive and contain trade secret or confidential commercial information
  • Changes that could affect device safety must be communicated to clients before implementation

Other considerations

  • Must submit two complete identical paper copies (or one paper copy and one microfiche)
  • Documents must be in English or accompanied by accurate English translations
  • Must include signed cover letter identifying submission as MAF
  • Authorization letters required for reference in client submissions
  • GMP requirements must be addressed when applicable
  • Foreign companies should retain a U.S. agent or representative
  • Information must be identified if considered trade secret or confidential
  • 21 CFR 820: Quality System Regulation
  • 21 CFR 20.61: Trade secrets and commercial or financial information

Original guidance

  • Device Master Files - Content, Format, and Submission Requirements
  • HTML / PDF
  • Issue date: 1987-06-01
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 47e9d5c09080d223888faeb869ec56c1
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