Device Master File
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.What this means in practice
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.- •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- •Letting a MAF go stale, FDA expects MAFs to be kept current and may not reference outdated content during review.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.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Pathway to classify novel low- to moderate-risk devices that lack a predicate.
FDA's most stringent device marketing application, required for high-risk Class III devices.
Compilation of records describing the design history of a finished device.
More in Regulatory
· Same categoryTwo alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny.
Primary references
3 sources- 1
Medical Device Master FilesVerifiedFDAfda.gov
- 2
FDA - Medical DevicesVerifiedFDAfda.gov
- 3
European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
Inline markers like [1] jump to the matching reference above.