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Etienne Nichols

FDA Compliance

What FDA QSR and ISO 13485 Harmonization Means for Medical Device Companies

Quality management system regulation explained

Published: Monday, March 28, 2022 - 11:03

On February 23, 2022, the FDA released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (QSR) with the international consensus standard for medical-device quality management systems, ISO 13485:2016.

Cue the applause—the medical device industry has been buzzing about harmonization between the FDA’s 21 CFR Part 820 and ISO 13485 since 2018, and now it’s finally happening.

Well, almost. The document the FDA released is a proposed rule. There are several steps before it’s finalized, including:
• Considering the recommendations of a public advisory committee meeting of the Device Good Manufacturing Practice Advisory Committee, which was held on March 2, 2022
• A 90-day public comment period about the regulation and subsequent revisions by the FDA
• A one-year period between finalization of the rule and its implementation

Still, this is a major step toward harmonization, and one that medical device professionals have been looking forward to for a long time.

So, let’s cut to the chase: Why is the FDA harmonizing the standards, what do the new changes look like, and what will this change for medical device companies?

Why is the FDA proposing this change?

Alrhough ISO 13485 has been revised repeatedly during the past two decades, the QSR remains nearly unchanged since it was released in 1996.

In its proposed rule, the FDA admits that “regulatory expectations for a QMS have evolved since the current part 820 was implemented over 20 years ago,” and that, “By proposing to incorporate ISO 13485 by reference, we are seeking to explicitly require current internationally recognized regulatory expectations for QMSs for devices subject to FDA’s jurisdiction.”

The FDA also notes that it has paid attention to the revisions to ISO 13485 over the years, and the agency feels the 2016 version of the standard is closely aligned with requirements of the QSR. All ISO standards are reviewed every five years to decide whether they need updating, and the current version of ISO 13485 was last confirmed in 2020.

The FDA repeatedly mentions in its proposed rule that the QMS requirements in Part 820 and ISO 13485 are substantially similar: “Where ISO 13485 diverges from the current part 820, these differences are generally consistent with the overall intent and purposes behind FDA’s regulation of QMSs.”

As such, it makes sense for the FDA to harmonize the two and eliminate the redundancy and inefficiency that many medical device companies face while attempting to satisfy the requirements of both the QSR and ISO 13485.

The agency believes that harmonization will further the cause of “regulatory simplicity and global harmonization and should reduce burdens on a regulated industry, thereby providing patients more efficient access to necessary devices.”

The FDA also estimates that harmonization will save medical device companies at least $439 million during the next decade by reducing the compliance burden on medical device companies that currently must comply with both standards.

How does the QMSR differ from the QSR?

The FDA is proposing to incorporate ISO 13485 “by reference,” meaning the new QMSR will address certain requirements by referencing their location in ISO 13485:2016. This will, of course, result in substantial changes to 21 CFR Part 820 as we know it.

The FDA states that it is “proposing additional definitions, clarifying concepts and additional requirements, all of which would require compliance within a manufacturer’s QMS in addition to ISO 13485.”

Many of these changes are semantic in nature and don’t change the basic QMS requirements for medical device companies. For instance, you’ll notice that the term “device master record” is nixed under the current proposal because it isn’t used in ISO 13485, and the concept behind it is adequately covered in ISO 13485’s requirement for a medical device file.

On the other hand, there are terms and definitions in ISO 13485 that “would create inconsistencies with the Federal Food, Drug & Cosmetic Act and its implementing regulations.” In these cases, the FDA’s definitions will supersede those of ISO 13485. For example, “device” and “labeling” will supersede the definitions for “medical device” and “labeling” in ISO 13485.

The FDA’s stance on the melding of Part 820’s definitions with those of ISO 13485 can be found in Section 5, Part B of the proposed rule.

The proposed rule also includes several new sections in Part 820:
Section 820.7—Incorporation by reference
Section 820.10Requirements for a quality management system
Section 820.15—Clarification of concepts
Section 820.35—Control of records
Section 820.45—Device labeling and packaging controls

Finally, one of the biggest differences between ISO 13485:2016 and the QSR is that the international standard places a greater emphasis on risk management.

The FDA notes that it expects manufacturers to integrate risk management activities throughout their QMS and across the product life cycle, but they also acknowledge that ISO 13485 more explicitly establishes those requirements. Incorporating ISO 13485 by reference will ensure the new QMSR has a more overt stance on the importance of risk management in design controls.

What does the FDA QSR transition to ISO 13485 mean for medical device manufacturers?

Although this may seem like a lot of change for medical device manufacturers, it’s important to keep in mind that the FDA already believes ISO 13485 to be substantially similar to the current QSR.

It’s a good idea to keep an eye on this proposed rule and any revisions to it that come out after the public comment period, but this won’t result in a total overhaul of your QMS. This harmonization is more about making life easier for everyone.

With that said, there are a few things to keep in mind regarding the proposed rule to harmonize the FDA QSR with ISO 13485:2016:
• Once the rule is finalized, there will be a one-year waiting period before it goes into effect.
• The proposed rule would also result in the replacement of the current Quality System Inspection Technique (QSIT) with a new approach that is consistent with the new QMSR requirements.
• The FDA is proposing to harmonize the QSR with ISO 13485:2016, which is the latest version of the ISO standard. Any future revision to ISO 13485 would first need to be evaluated by the FDA before being incorporated into the QMSR.
• Just because QMSR will be harmonized with ISO 13485 doesn’t mean you’ll be issued an ISO 13485 certification of conformance after an inspection. And if you already are ISO 13485-certified, that won’t exempt you from an FDA inspections.

Finally, remember this is a proposed rule and it’s all still subject to change. Still, this is an excellent opportunity to read up on how FDA views the relationship between the QSR and ISO 13485 and how it currently plans on harmonizing the two.

First published March 2, 2022, on the Greenlight Guru blog.


About The Author

Etienne Nichols’s picture

Etienne Nichols

Etienne Nichols is a medical device guru and mechanical engineer who loves learning and teaching how systems work together. With a Project Management Professional (PMP) certification, Nichols is experienced in manufacturing and product development aiding in the development of combination drug-delivery devices.