Confidential FDA submission allowing a supplier to share proprietary information with multiple device manufacturers' submissions without disclosing it to them.

Definition

A Device Master File (MAF) is a voluntary submission to FDA containing detailed confidential information about facilities, processes, components, materials, or methods used in the manufacture, processing, or packaging of medical devices. It is filed by a supplier (the MAF holder) and can be referenced by multiple device manufacturers (submitters) via a Letter of Authorization. This allows a supplier, for example, a contract sterilizer, a component manufacturer, a packaging supplier, or a custom resin formulator, to disclose trade secrets to FDA while sharing only what's necessary with downstream customers.

Why it matters

Device MAFs are the standard mechanism for protecting supplier IP across the device supply chain. Common MAF use cases include ethylene oxide sterilizer parameters, custom polymer or alloy formulations, contract manufacturer process details, and packaging system performance data. Submitters must reference the MAF by number in their 510(k), De Novo, PMA, or IDE submission along with a copy of the Letter of Authorization. MAFs are reviewed only in the context of referencing submissions; FDA does not issue independent approvals or decisions on a MAF itself.

Common pitfalls

•Submitting a MAF without coordinating with downstream customers, without a Letter of Authorization and the right MAF number in the customer's submission, the content is invisible to reviewers.
•Letting a MAF go stale, FDA expects MAFs to be kept current and may not reference outdated content during review.
•Confusing Device MAF with Drug Master File (DMF), they serve similar purposes but follow different procedures and are managed by different FDA centers.

Sources

21 CFR 814.20, PMA content (incorporation by reference of master files) · eCFR
FDA - Medical Devices · FDA
European Commission - Medical Devices · European Commission
FDA Device Master Files · FDA

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Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

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