FDA 483 Citations for the Device Master Record Under 21 CFR 820.181

"A device master record has not been [adequately] maintained." FDA investigators cited 21 CFR 820.181 with that wording 30 times on system-generated Form FDA 483s in fiscal year 2025.

The device master record (DMR) is the recipe for a device: everything needed to build, inspect, package, label and service it. When the DMR is incomplete, production depends on what people remember, and lots built months apart may not be the same device. Under QMSR, the same expectation continues as the medical device file.

What the citations mean

Examples written after "Specifically" usually describe:

• No DMR, or a DMR that is only a bill of materials

• Specifications for components, materials or software missing

• Production processes, equipment settings or work instructions not referenced

• Acceptance criteria, inspection procedures and test methods not identified

• Packaging and labeling specifications not included

• Installation, maintenance or servicing procedures missing for devices that need them

• An index that points to obsolete revisions or documents that do not exist

• DMR documents that were not approved under document control

What 21 CFR 820.181 required

Under the Quality System Regulation, each manufacturer had to maintain DMRs, and each type of device had to have a DMR prepared and approved in accordance with document control (820.40). The DMR had to include, or refer to the location of:

• Device specifications, including appropriate drawings, composition, formulation, component specifications and software specifications

• Production process specifications, including the appropriate equipment specifications, production methods, production procedures and production environment specifications

• Quality assurance procedures and specifications, including acceptance criteria and the quality assurance equipment to be used

• Packaging and labeling specifications, including methods and processes used

• Installation, maintenance and servicing procedures and methods

What changed under QMSR

Under QMSR, in effect since February 2, 2026, the DMR requirement comes from ISO 13485:2016 clause 4.2.3, Medical device file. For each medical device type or family, the organization must establish and maintain one or more files either containing or referencing documents generated to demonstrate conformity to the requirements of ISO 13485 and compliance with applicable regulatory requirements. The content must include, but is not limited to:

• A general description of the device, intended use or purpose, and labeling, including any instructions for use

• Specifications for product

• Specifications or procedures for manufacturing, packaging, storage, handling and distribution

• Procedures for measuring and monitoring

• As appropriate, requirements for installation

• As appropriate, procedures for servicing

The medical device file is broader than the old DMR. It adds the intended use, labeling and distribution requirements, and it must show conformity, not only list how to build the device. Documents in the file remain subject to document control under clause 4.2.4.

How to respond to the 483

FDA generally considers responses received within 15 business days of the close of the inspection before deciding on further action.

Build or complete the file for the cited device

Create an index for the cited device that lists or links every required element, with document numbers and current revisions. Approve it under document control.

Check production against the file

Compare what production actually does with the documented specifications and instructions. Where practice and documents differ, decide which is correct, update the documents or retrain, and assess product built under the undocumented practice.

Extend to every device family

Build medical device files for all device types or families on the market, prioritized by risk. Give FDA the schedule.

Connect the file to change control

Make the file the reference for every engineering change. A change that affects a specification, process or label must update the file index.

What a compliant medical device file procedure contains

• Scope by device type or family

• Required content under ISO 13485 clause 4.2.3 and FDA requirements

• File index format and ownership

• Links to design outputs and design transfer

• Approval and change control under document control

• Periodic review to keep the index current

• Access for production, quality and regulatory staff

Common mistakes in DMR responses

• Producing an index that lists documents nobody uses

• Leaving out software, packaging or labeling specifications

• Forgetting servicing and installation documents

• Updating the file once and not linking it to change control

• Treating the medical device file as a regulatory submission rather than a working production reference

Example: how one response section might read

This illustrates structure only; your response must describe your own facts.

Observation 6: A device master record has not been adequately maintained. Specifically, the DMR for the infusion set does not include packaging specifications or the sealing process parameters.

Response:

• Correction: A medical device file index for the infusion set was approved on a stated date. It references the packaging specification, the validated sealing parameters and the labeling specification.

• Product assessment: Sealer settings in production records for the last 12 months were compared with the validated parameters. All were within range.

• Extended review: Files for the remaining six device families will be completed on a dated schedule, with the highest-risk families first.

• Root cause: The DMR was created at launch as a bill of materials and was not updated as processes were validated.

• Corrective action: The engineering change procedure now requires the file index to be updated as part of every change.

Frequently asked questions

Is the device master record still required under QMSR?

QMSR does not use the term, but ISO 13485 clause 4.2.3 requires a medical device file for each device type or family. It covers everything the DMR did and more.

Does the file have to be one document?

No. It can be one or more files that contain or reference the required documents. An approved index that points to controlled documents is common.

How does the medical device file relate to the design and development file?

The design and development file (clause 7.3.10) records how the design was developed and verified. The medical device file is the current definition of the device and how to make it.

How A.P. Lyon documents help

A.P. Lyon's Device Master Record and Technical Documentation Procedure defines the medical device file, its index and how it stays current. It works with the Specification Format Procedure, the Engineering Change Notice Procedure and the Device History Record Procedure.

Documents are editable Word and Excel files and must be adapted to your devices and organization. The technical content of each file must come from your own engineering.

Next steps

• Complete the medical device file for the cited device

• Compare production practice with the file and fix differences

• Schedule files for every device family

• Respond within 15 business days with dates for each action

Related guides: Device History Record Citations and Design Control Citations.

To build a complete set of procedures at a volume discount, use Build Your QMS. For help with a 483 response, see A.P. Lyon consulting services.

Not sure where your quality system stands? Take the free QMS gap check: about 20 questions, an instant report of your gaps by clause, and the procedures that close each one.