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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.
    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    • •Letting a MAF go stale, FDA expects MAFs to be kept current and may not reference outdated content during review.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.

    Primary references

    3 sources
    Link health: 1 verified 2 bot-blocked· last checked 2026-06-20
    FDA·2European Commission·1
    1. 1
      Medical Device Master Files
      Bot-blocked
      FDAfda.gov
    2. 2
      FDA - Medical Devices
      Bot-blocked
      FDAfda.gov
    3. 3
      European Commission - Medical Devices
      Verified
      European Commissionhealth.ec.europa.eu

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