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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.”
What FDA QSR and ISO 13485 Harmonization Means
QMSR for medical device companies
Is it built specifically for medtech? Does it help you achieve truly paperless audits? Does it come with a top-notch team of medical device experts who are always ready to help?
That’s why the agency is introducing a new labeling and packaging clause to the proposed Part 820.
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That last one, 820.45, could use a little more attention. In the proposed QMSR ruling, the FDA pointed out that there are device recalls every year related to product labeling and packaging. Clause 7.5.1(e) of ISO 13485 states that “defined operations for labeling and packaging shall be implemented,” but the FDA doesn’t seem to think this goes far enough.
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.
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?
If you answered no to any of those questions, it’s probably time to modernize your QMS.
The FDA states 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.”
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.”
Cue the applause, because the medical device industry has been buzzing about harmonization between FDA’s QSR and ISO 13485 since 2018 and now it’s finally happening.
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
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.
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Although ISO 13485 has been revised repeatedly over the past two decades, the QSR remains nearly unchanged since it was released in 1996.
Well, almost. The document the FDA released is a proposed rule. Right now, the agency asserts that publication of the final rule in the Federal Register will happen Dec. 00, 2023. (Yes, you read that “00” correctly. The agency seems to be giving itself a bit of wiggle room on exactly when it will be published.)
The FDA’s stance on melding Part 820’s definitions with those of ISO 13485 can be found in Section 5, Part B of the proposed rule.
The main items that Section 820.45 will require are:
• UDI or UPC
• Expiration date
• Storage instructions
• Handling instructions
• Processing instructions
There will also be at least a one-year period between the finalization of the rule and its implementation. That means December 2024 is the earliest the QMSR could go into effect. Still, this is a major step toward harmonization, and one that medical device professionals have long been waiting for.
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.
First published July 21, 2023, on the Greenlight Guru blog.