What FDA QSR and ISO 13485 Harmonization Means

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The proposed rule also includes several new sections in Part 820:
Section 820.7: Incorporation by reference
Section 820.10: Requirements 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

If you’re already ISO 13485-certified
If you’re already certified to ISO 13485:2016, that’s a great start—but it doesn’t mean you’ll automatically be in compliance with the QMSR. Remember, the FDA is adding these new sections on top of what’s currently in ISO 13485:
Section 820.7: Incorporation by reference
Section 820.10: Requirements 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

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 that the new QMSR has a more overt stance on the importance of risk management in design controls.

The good news is, 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.

December 2024 might sound like it’s pretty far off today, but that actually makes this the perfect time to begin thinking about how you’ll get compliant with the QMSR.

It’s a good idea to keep an eye on this proposed rule and any revisions that may occur prior to December 00. But this shouldn’t result in a total overhaul of your QMS. This harmonization is more about making life easier for everyone.

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.

December 2024 will be here sooner than you think, so it’s worth it to start looking at your current labeling and packaging procedures now and start getting them in line with what will be expected.

Why is the FDA proposing this harmonization?

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

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 21 CFR Part 820. All ISO standards are reviewed every five years to decide whether they need updating. The current version of ISO 13485 was last confirmed in 2020.

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 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.”

It’s a good idea to become familiar with these sections of the QMSR now and consider how you’ll achieve compliance with their requirements, even if you’re currently in conformity with ISO 13485:2016.

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 have to comply with both standards.

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

While 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.

First published July 21, 2023, on the Greenlight Guru blog.

If you answered no to any of those questions, it’s probably time to modernize your QMS.

The main items that Section 820.45 will require are:
• UDI or UPC
• Expiration date
• Storage instructions
• Handling instructions
• Processing instructions