--- title: "MAF, Device Master File | MedTech Terms" description: "Confidential FDA submission allowing a supplier to share proprietary information with multiple device manufacturers' submissions without disclosing it to them." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/device-master-file#term", "name": "Device Master File", "alternateName": [ "MAF", "MAF (Master Access File)", "Medical Device Master File" ], "description": "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. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Device Master File [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)[Manufacturing & Supply](/ecosystems/manufacturing-supply)MAF # Device Master File Confidential FDA submission allowing a supplier to share proprietary information with multiple device manufacturers' submissions without disclosing it to them. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed June 20, 2026 ## 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 the regulation says FDA's Master Files program for devices is described in the agency's 'Medical Device Master Files' page and is operated by CDRH. Master Files are entirely voluntary and do not constitute FDA approval of the contents. ## 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](/terms/de-novo), [PMA](/terms/pma), or [IDE](/terms/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. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory De Novo Classification Request(De Novo) Pathway to classify novel low- to moderate-risk devices that lack a predicate. ](/terms/de-novo)[ Regulatory Premarket Approval(PMA) FDA's most stringent device marketing application, required for high-risk Class III devices. ](/terms/pma)[ Quality & Risk Design History File(DHF) Compilation of records describing the design history of a finished device. ](/terms/design-history-file) ### More in Regulatory · Same category [ Regulatory 510(k) Summary vs 510(k) Statement Two 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. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k)[ Regulatory Accreditation Scheme for Conformity Assessment(ASCA) FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny. ](/terms/asca) Cited by Where this term appears across MedTech Terms. Ecosystems (3) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) - [Manufacturing & Supply](/ecosystems/manufacturing-supply) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 2 European Commission· 1 1. [1 Medical Device Master Files Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/master-files) 2. [2 FDA - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices) 3. [3 European Commission - Medical Devices Verified European Commission · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Acronym MAF Sources 3 Updated 6/20/2026 [Compare with another term](/compare?a=device-master-file) Learn in 60 seconds Card Lesson Quiz Confidential FDA submission allowing a supplier to share proprietary information with multiple device manufacturers' submissions without disclosing it to them. - · 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. Remember this Watch out: 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. Related terms - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [Premarket Approval(PMA) ](/terms/pma) - [De Novo Classification Request(De Novo) ](/terms/de-novo) - [Investigational Device Exemption(IDE) ](/terms/ide) - [Design History File(DHF) ](/terms/design-history-file) - [Supplier Controls ](/terms/supplier-controls) You may also need Auto-suggested from Regulatory and shared keywords. - [510(k) Summary vs 510(k) Statement ](/terms/510k-summary-vs-statement) - [Algorithm Change Protocol(ACP) ](/terms/algorithm-change-protocol) - [Emergency Use Authorization(EUA) ](/terms/eua) - [Genetic Testing Requirements (IVDR Article 4) ](/terms/ivdr-genetic-testing) - [Instructions for Use(IFU) ](/terms/ifu) - [Letter to File(LTF) ](/terms/letter-to-file) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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