QMSR & the End of DMR, DHR, DHF: How FDA’s New Rule Impacts Record-Keeping

June 4, 2024

QMSR & the End of DMR, DHR, DHF How FDA’s New Rule Impacts Record-Keeping

If you’re a MedTech professional who’s been working with the Quality System Regulation (QSR) in the US, then you’re probably familiar with the three terms FDA uses for record-keeping requirements:

  • Device Master Record (DMR): a compilation of records containing the procedures and specifications for a finished device.

  • Design History File (DHF): a compilation of records which describes the design history of a finished device.

  • Device History Record (DHR): a compilation of records containing the production history of a finished device.

The DMR, DHF, and DHR have been around for decades, but in the FDA’s Final Rule on the new Quality Management System Regulation (QMSR), these terms don’t make an appearance.

Many people who read the proposed rule commented on this omission, given that these terms describe much of the record-keeping requirements for medical device companies. Well, in the comments and responses section of the Final Rule (comment 31), FDA responded to these concerns and elaborated on why they’re moving on from the DMR, DHF, and DHR. 

In this article, I’m going to explain FDA’s decision and give you a couple of my own thoughts on what this means for medical device manufacturers going forward. 

BONUS RESOURCE: Click here to download a free FDA QSR, QMSR & ISO 13485:2016 Internal Audit Checklist.

Why aren’t DMR, DHR and DHF named in the QMSR?

The answer to this question is pretty straightforward. The QMSR is incorporating ISO 13485:2016 by reference, and ISO 13485:2016 doesn’t use these three terms. Instead, it uses the term Medical Device File (MDF) to refer to all the records that are traditionally split up amongst the DMR, DHR, and DHF

Here’s what FDA said about it in the Final Rule: 

The recordkeeping requirements in ISO 13485 are substantively similar to those in the QS regulation and, because there is no reference to these terms in ISO 13485, we have eliminated this terminology as it is no longer necessary. Retaining the definition of the DMR in the QMSR would, therefore, be redundant and could lead to confusion and misinterpretation of the requirements of the QMSR.

In other words, let’s keep things simple. FDA doesn’t see a good reason to use three very similar terms anymore when there’s one perfectly good term that will do. 

Keep in mind, this doesn’t mean that record-keeping requirements are changing in any major way. The agency goes on to say:

We are not retaining separate requirements for these record types in the QMSR and have eliminated terms associated with these specific record types because we believe the elements that comprise those records are largely required to be documented by ISO 13485, including Clause 4.2 and its subclauses, and Clause 7 and its subclauses.

Basically, they feel that ISO 13485:2016 already requires what’s in the DMR, DHF, and DHR. It’s the terminology that FDA will be using that’s changing, not the record-keeping requirements.

How do record-keeping requirements in ISO 13485 compare to the Quality System Regulation?

Given that we’ll all be working with ISO 13485:2016 in less than two years, it’s worthwhile to take a look at the record-keeping requirements in the standard and compare them to the DMR, DHR, and DHF. 

Let’s start with Clause 4.2, which FDA called out specifically in the Final Rule. Subclause 4.2.3 medical device file requires manufacturers to “establish and maintain one or more files… including but not limited to” the following items:

  1. General description of the medical device, intended use/purpose, and labeling, including any instructions for use

  2. Specifications for the product

  3. Specifications or procedures for manufacturing, packaging, storage, handling, and distribution

  4. Procedures for measuring and monitoring

  5. Any requirements for installation and procedures for servicing

This is the subclause that matches up well with FDA’s current requirements for the DMR.

If we go on to clause 7.3, we can find an approximate requirement for the DHF. Each subclause of 7.3, which lays out the design and development process, calls for all documents and records relating to the design of the device to be maintained. In other words, “a compilation of records which describes the design history of a finished device.”

And in subclause 7.5.1, Control of production and service provision, we find a requirement for the manufacturer to “establish and maintain a record for each medical device or batch of medical devices that provides traceability to the extent specified in 7.5.9 and identifies the amount manufactured and amount approved for distribution.” These are essentially the requirements for a DHR.

What I’m trying to get at here is that the QMSR isn’t going to change the records you need to keep. The wording is different, sure, but the goal of this record-keeping is the same. FDA even says they “expect the burden to be similar to requirements associated with record types in the QS regulation.”

What does the elimination of the DMR, DHF and DHR terminology mean for medical device companies?

Here’s the thing about language—it’s not always easy to change it on a whim. And just because the DMR, DHF, and DHR aren’t referenced in the QMSR doesn’t mean no one will ever use them again. I’d hazard a guess that many MedTech professionals will continue using DMR, DHR, and DHF when referring to the various records that fall under the umbrella of the MDF. 

Think of it as the kind of tribal knowledge that’s typical in many professions. For instance, terms like “first article inspection” (FAI) and “critical to quality” (CTQ) don’t appear in 21 CFR Part 820, but they’re ubiquitous in MedTech. I have a feeling that the same thing will happen with the old record-keeping terms. 

FDA even alludes to this in their response to comment 31, stating that they recognize “each organization will implement a QMS specific to its requirements regarding device safety and effectiveness, including with respect to records and documentation.”

What we do need to be thinking about, however, is the next generation of MedTech professionals. In just a few years they’ll be coming into the industry without any experience with the “old” part 820, and there will be nothing in the regulation referring to the DMR, DHF, or DHR.

So, for their sake, and for the sake of the future auditors who will navigate your QMS documents, it’s important to update the reference or definitions section of your QMS to clarify what different sets of documents should be called and what synonyms exist for them.

BONUS RESOURCE: Click here to download a free FDA QSR, QMSR & ISO 13485:2016 Internal Audit Checklist.

Choose a QMS built to FDA and ISO 13485:2016 requirements

The truth is that the QMSR is not going to result in major changes to the requirements for establishing and maintaining a compliant QMS. But it is important to keep up with changing regulations and, yes, terminology. And at Greenlight Guru, we think it’s a good idea to use a QMS solution that also keeps up with the latest regulatory changes and best practices in the medical device industry. 

With Greenlight Guru Quality, you can ensure compliance from the very start with purpose-built QMS software that comes pre-validated to 21 CFR Part 820, ISO 13485:2016, and ISO 14971:2019. You’ll rest easy knowing that we’re also keeping up with the latest regulatory changes and best practices in the MedTech industry, so you’ll never be caught off guard by a change.

Ready to see how Greenlight Guru Quality can remove the regulatory burden and help you ensure compliance? Get your free, personalized demo today →

Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...

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