The record survived. The acronym didn't.

Three terms used to anchor a device quality system’s paperwork: the Design History File, the Device Master Record, the Device History Record. Every quality manual written before February 2026 organizes itself around them. None of the three is defined in Part 820 anymore.

Three definitions, three sections, one amendment

Under the Quality System Regulation as it stood for three decades, 21 CFR 820.3 defined the Design History File as the compilation of records describing a device type’s design history, the Device Master Record as the compilation of specifications and procedures for building it, and the Device History Record as the compilation of records showing a specific unit or lot was actually built to those specifications. Three substantive sections carried the duty: 820.30(j) required a DHF inside design controls, 820.181 listed exactly what a DMR had to contain, and 820.184 required a DHR for every unit or batch. All three sat in the part’s own text, citable by number, enforceable on their own terms.

FDA’s February 2, 2024 final rule retitled Part 820 the Quality Management System Regulation and incorporated ISO 13485:2016 by reference, effective February 2, 2026. This blog has already described what that amendment did to Part 820’s structure generally — most of the section numbers industry learned by heart are reserved, not deleted, pointing nowhere now that the rule’s own text moved into 820.10 and the incorporated standard. The three records sections are not an exception to that pattern. 820.30(j), 820.181, and 820.184 are reserved along with the rest, and the definitions themselves are gone from the current 820.3.

The record survived. The acronym didn’t.

What replaces them

Nothing in the current Part 820 text restates Design History File, Device Master Record, or Device History Record as defined terms, under those names, anywhere a device firm can cite them. What the rule does instead is route the underlying recordkeeping through 820.10 into ISO 13485:2016 generally, the same mechanism that now carries design controls and complaint handling. ISO 13485 organizes its own records differently than Part 820 did, and the standard’s text isn’t something FDA Radar holds or quotes — standards content is copyrighted and sold by the standards bodies, which is exactly why this product doesn’t monitor it directly today. Compliance commentary published since the rule took effect reads the old DHF and DMR functions into particular ISO 13485 clauses. That reading may well be right. It is also commentary, not a sentence that exists anywhere in the amended regulation itself — a distinction worth keeping, given how much of this product’s own editorial standard rests on not treating the second kind of claim as the first.

The practice

A firm’s internal SOPs, audit checklists, and training materials that still say “maintain the DMR” aren’t necessarily out of compliance for saying so — nothing in the rule bars a company from keeping its own vocabulary. But a citation that leans on the regulation itself to defend that vocabulary is leaning on sections that are empty. An auditor, a new quality hire, or a consultant reading an old SOP that cites 820.181 by number is reading a citation to a reserved section, not an operative one, and tracing what that SOP is actually supposed to satisfy now runs through 820.10 into ISO 13485, not back to 820.181. Whether a specific firm’s existing DMR binder or DHF folder, organized under the old names, actually satisfies what ISO 13485 now asks for in substance is a determination for the quality or regulatory professional who owns that file — the terms vanishing from the rule’s text is a fact about the regulation, not a verdict on any one company’s records.

Reading the old DMR, DHF, and DHR sections against the current, mostly empty text is the same exercise this blog described for 820.30 and 820.100 when the broader renumbering first posted — just three more addresses on the same list.