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.
What You Need to Know? 👇
What is a Master File (MAF) for medical devices and when should it be used?
A Master File (MAF) is a confidential document submitted to FDA containing trade secret information about ingredients, manufacturing processes, or facilities used by third parties in medical device production. It’s used when device manufacturers need to reference proprietary information without direct access to trade secrets.
What types of information can be included in a device Master File?
MAFs can contain five main types of information: facilities and manufacturing procedures, synthesis and specifications for chemicals/materials/subassemblies, packaging materials and contract manufacturing, nonclinical study data, and clinical study data. All information must be substantive and confidential in nature.
How do I authorize a client to reference my Master File in their FDA submission?
Provide a signed authorization letter on company letterhead directly to your client. The letter must specify the MAF number and the client’s device. Include the original in their submission’s original copy and copies in subsequent copies. Don’t send authorization letters directly to FDA.
What are the formatting requirements for submitting a Master File to FDA?
Submit two identical paper copies (or one paper plus microfiche). Use standard 8.5”x11” paper, number all volumes and pages, bind on the left with 3/4” margin, and limit volumes to 2 inches thick. Don’t use book binding or spiral binding.
Can Master File information be disclosed under the Freedom of Information Act?
Yes, MAF information referenced in approved submissions may be subject to FOI disclosure unless it qualifies as trade secret or confidential commercial information under 21 CFR 20.61. MAF holders should clearly identify confidential information and note that publicly available information is subject to disclosure.
What happens if I need to update information in my submitted Master File?
You can amend your MAF by submitting updates to the same FDA address. However, you must notify clients before making changes that could affect their approved devices, as this impacts their compliance with FDA regulations and product liability obligations.
What You Need to Do 👇
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 đź“‚
- 21 CFR 820: Quality System Regulation
- 21 CFR 20.61: Trade secrets and commercial or financial information