How does a device manufacturer actually reference a supplier's MAF in a 510(k) or PMA submission?

The device manufacturer (submitter) must cite the MAF number in their submission and include a copy of the supplier's Letter of Authorization granting FDA permission to review the referenced MAF content in the context of that submission; without both the correct MAF number and the Letter of Authorization on file, the referenced content is effectively invisible to the FDA reviewer.

Does FDA independently approve or review a Device Master File on its own?

No, FDA does not issue independent approvals or decisions on a MAF by itself, the content is reviewed only in the context of the specific submissions (510(k), De Novo, PMA, or IDE) that reference it, which means a MAF holder cannot rely on the file having been 'approved' independently of a submitter's application.

What is the difference between a Device Master File and a Drug Master File?

Both serve the similar purpose of letting a supplier share confidential manufacturing information with FDA for reference by multiple customers, but the Device MAF is managed under CDRH's device master file program while the Drug Master File (DMF) is managed under FDA's drug centers with different procedures and content expectations, so manufacturers should not assume the two programs are interchangeable when coordinating supplier documentation.

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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 CyberLast 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, 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.

Examples

Illustrative: A manufacturer of a critical implantable component submits an MAF containing proprietary material composition and manufacturing process details, which several medical device companies reference in their premarket submissions for various implantable devices.
Illustrative: A contract sterilization facility files an MAF detailing its unique ethylene oxide sterilization cycle parameters and validation data, allowing multiple device manufacturers to efficiently incorporate their sterilization methods into their regulatory submissions without disclosing trade secrets.
Illustrative: A specialized packaging supplier uses an MAF to protect its innovative sterile barrier system design and performance testing, which is then referenced by MedTech companies needing validated packaging for their sterile devices.

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.

Frequently asked questions

A Device Master File (MAF) is a voluntary, confidential submission to FDA containing detailed proprietary information about facilities, processes, components, materials, or methods used in manufacturing, filed by a supplier such as a contract sterilizer, component manufacturer, packaging supplier, or resin formulator so they can disclose trade secrets to FDA without revealing that information directly to the device manufacturers who use their products.

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4 sources

Sources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

Official-source claim check: 2026-11-01

FDA MAFs permit authorized confidential cross-reference and are not independently approved.

Partial review: verified corrections are applied, but this is not a full accuracy certification. The last full review date is unchanged.

Remaining verification limits

Original merged record reviewed in full. Illustrative examples are hypothetical, not verified case histories. Evidence supports the specific propositions below, not an assertion that every linked page verifies all merged content.

Tier 1Binding law and standards· 1Tier 2Regulator guidance and consensus· 3

Link health: 2 verified 2 unchecked· last checked 2026-06-20

eCFR·1FDA·2European Commission·1

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Category: Regulatory
Acronym: MAF
Sources: 4
Updated: 6/20/2026

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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.

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