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.
Recommended Actions
- Determine if information qualifies for MAF submission (trade secret/confidential nature)
- Prepare documentation following format requirements (two copies, proper binding, pagination)
- Include comprehensive cover letter with required information
- Establish process for managing authorizations to clients
- Implement system for tracking and submitting amendments
- For foreign companies, designate U.S. agent/representative
- Clearly mark confidential/trade secret information
- Establish procedure for notifying clients of changes
- Ensure GMP compliance where applicable
- 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
Related references and norms
- 21 CFR 820: Quality System Regulation
- 21 CFR 20.61: Trade secrets and commercial or financial information
Original guidance
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