Device History Record Example: Contents, Review, and QMSR Rules

A device history record example is easiest to picture as a physical or electronic packet tied to one production run: for a lot of 5,000 infusion pumps, the packet would hold the manufacturing work order with start and end dates, an accounting showing 5,000 units built with 4,972 released and 28 rejected, the inspection and electrical safety test sheets, physical copies of the product label and the instructions for use booklet, and the unique device identifier and lot number assigned to the batch. Every document traces back to a specification in the Device Master Record. That packet, in whatever form the manufacturer keeps it, is the device history record (DHR). Federal rules require one for every batch, lot, or unit produced, and as of February 2, 2026, those requirements sit inside the new Quality Management System Regulation aligned with ISO 13485.¹

How the DHR Differs From the DHF and DMR

Three documentation sets get confused constantly, and the difference matters before you start compiling anything. The Design History File captures the history of the design process and shows that development followed FDA design control requirements. The Device Master Record is the recipe: specifications, drawings, production procedures, quality assurance methods, and labeling specs needed to build the device consistently. The Device History Record proves that a specific production run actually followed that recipe.

Put another way: the DHF shows how the product was designed, the DMR shows how it should be built, and the DHR shows how it was built. When an FDA investigator reviews a DHR, they compare it against the DMR to confirm the finished product matches the approved specifications. Any gap between the two is a finding.

What Has to Be Inside

The former rule at 21 CFR 820.184 set out six categories of information every DHR must contain or reference, and the QMSR carries the same expectations forward through ISO 13485 Clause 7.5.1.²³ Those categories are:

Dates of manufacture — when production started and finished for the batch, lot, or unit.
Quantity manufactured — the total number of units produced in the run.
Quantity released for distribution — how many units passed final review and shipped.
Acceptance records — test results, inspection data, and pass/fail outcomes showing the device conforms to the DMR.
Primary identification label and labeling — copies of the actual labels, instructions for use, and warnings applied to each production unit.
Device identification and control numbers — any UDI, universal product code, serial number, or lot/batch control number used.

Return to the infusion pump lot. Each of the six categories has a real document behind it in that packet, and each of those documents has a counterpart in the DMR that an inspector can hold up next to it.

Manufacturing Dates

Recording both start and completion dates matters because it lets a manufacturer pinpoint which lots might be affected if a raw material defect or equipment malfunction is discovered later. For multi-step production processes that span several days, each major process step should carry its own date stamp so the timeline is traceable end to end.

Quantity Reconciliation

Quantity tracking goes beyond counting the units that came off the line. The DHR must reconcile three numbers: how many units were manufactured, how many were rejected or scrapped during production, and how many were released for distribution.² Quantity released is its own required data point, separate from quantity manufactured. If those figures don’t add up, an investigator will want to know where the missing units went. During a recall, regulators expect the manufacturer to know exactly how many devices from a given lot reached the market. Discrepancies in quantity records are among the faster paths to a Form 483 observation.

Device Identification and Labeling

Every device in a production run needs to be traceable through identification numbers. The DHR must capture the UDI or universal product code assigned to the batch, along with any lot, batch, or serial numbers used for tracking.² These identifiers connect the physical product to its production records for the device’s entire commercial life. For devices that contain software, the installed firmware or software version should also be documented, because a different version effectively creates a different product.

Labeling documentation means retaining a copy of the actual labels applied to the device and its packaging during that specific run. That includes the primary product label, the instructions for use, and any warning inserts. The copies must match the approved labeling specifications in the DMR exactly. Applying the wrong label revision or omitting a required warning can trigger misbranding charges under federal law, so inspectors look for evidence that someone verified the labels before the product left the facility.

Acceptance Records

Acceptance records are the evidentiary core of the file. They demonstrate that the finished product conforms to DMR specifications.² Each inspection and test must show a clear pass or fail outcome; “within tolerance” without the actual measurement is not enough. The record should include the raw test data, the acceptance criteria it was measured against, and the identity of the person who performed the test.

The specific tests depend on the device. An electrical device might require dielectric strength readings and leakage current measurements. A sterile device would include bioburden results and sterilization validation. A device with embedded software needs software validation results. Whatever the tests, the DHR must show that every required verification step in the DMR was completed and that the results fell within the approved criteria.

When signatures are captured electronically rather than on paper, the electronic records system must comply with 21 CFR Part 11.⁴ Practically, the system must link each signature to a unique user, timestamp the signing action, and prevent unauthorized alteration of signed records.

Non-Conformances and Rework

Not every unit passes inspection on the first attempt, and the DHR has to account for what happened to the ones that didn’t. When a product fails to meet specifications, the manufacturer must evaluate the nonconformance and decide whether an investigation is needed. Both the evaluation and any resulting investigation must be documented.⁵

If the manufacturer decides to rework nonconforming units rather than scrap them, the rework activities and subsequent retesting must be documented, including an assessment of whether the rework introduced any adverse effect on the product.⁵ If a circuit board fails a functional test and is resoldered, the DHR should record what failed, what rework was performed, and the retest results confirming the board now meets specifications.

If a nonconforming unit is released under a concession rather than reworked, the DHR must include the justification for that decision and the signature of the individual who authorized the release. A pattern of accepting out-of-spec product without adequate justification raises serious questions about the quality system.

Review, Approval, and Retention

Before any product from a batch ships, the complete DHR must be reviewed and approved. A designated quality representative gathers the manufacturing records, labeling copies, acceptance data, and any non-conformance documentation into a single packet and checks that every required element is present and complete. Blank fields or missing test results stop the process until the gap is resolved.

Final sign-off may be a physical signature or an authenticated electronic approval. Once approved, the DHR transitions from an active production document to a permanent record filed within the company’s document control system. The person who signs is attesting that the record demonstrates compliance.

Federal regulations require manufacturers to retain quality system records, including DHRs, for a period equivalent to the design and expected life of the device, with a minimum of two years from the date of commercial release.⁶ For implantable devices or long-life capital equipment, that can mean decades of storage. Records must remain accessible for regulatory review throughout the retention period, whether stored on paper, in a validated electronic system, or in a hybrid.

Electronic DHR Systems and Data Integrity

Many manufacturers have moved from paper to electronic DHR platforms, often called eDHR systems. An electronic system can enforce the production workflow by preventing operators from skipping steps, automatically capturing timestamps, and flagging out-of-spec readings in real time. Those advantages come with their own obligations.

Any electronic system used for DHR records must include a secure, computer-generated audit trail that logs every record creation, modification, or deletion. Each entry needs a timestamp, the identity of the user who made the change, what was changed, and why. The audit trail itself must be permanent and protected from deletion; if someone can alter the trail, it has no evidentiary value.

The FDA expects production data to meet what the industry calls ALCOA+ standards: attributable, legible, contemporaneous, original, and accurate, plus complete, consistent, enduring, and available. Those principles apply to paper and electronic records alike, but a validated eDHR system with proper access controls, automated backups, and a robust audit trail will satisfy them more reliably than a binder in a filing cabinet.

What Changed Under the 2026 QMSR

On February 2, 2026, the FDA’s revised Part 820 took effect under the name Quality Management System Regulation, replacing the Quality System Regulation that had governed device manufacturing since 1996 and incorporating ISO 13485 by reference.¹ The old section numbers, including 820.184 for device history records, no longer appear in the current Code of Federal Regulations.

The practical impact on DHR content is smaller than the restructuring suggests. The production record requirements that lived in 820.184 now sit primarily in ISO 13485 Clause 7.5.1, covering the control of production and service provision.³ Manufacturers still need to record dates, quantities, acceptance results, labeling, and device identification. The QMSR also added a specific requirement to record the UDI for each device or batch. Companies that already maintained thorough DHRs under the former regulation are well positioned; the documentation itself doesn’t change much, even if the regulatory citation on the audit checklist does.

1
Food and Drug Administration. Quality Management System Regulation Frequently Asked Questions
2
eCFR. 21 CFR 820.184 – Device History Record
3
Federal Register. Medical Devices; Quality System Regulation Amendments
4
eCFR. 21 CFR Part 11 – Electronic Records; Electronic Signatures
5
GovInfo. 21 CFR Part 820 – Quality System Regulation – Section 820.90
6
eCFR. 21 CFR 820.180 – General Requirements