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4 Things To Know About the 21 CFR Part 820/ISO 13485 Harmonization


Medical device quality manager working online and learning about the FDA ISO 13485 harmonization.

The long-awaited harmonization between 21 CFR 820 and ISO 13485 finally got a kickstart! If those letters and numbers mean nothing to you, they’re the quality system regulation and the medical device quality management system standard from ISO, respectively. The U.S. Food and Drug Administration (FDA) recently released a draft guidance that would make it easier for medical device companies to comply with FDA regulations and the standard from the International Organization for Standardization (ISO).

This harmonization is one of the medical device trends to keep an eye on in 2023. While the final rule hasn’t been issued, here are four things you should know.

  1. 21 CFR Part 820 and ISO 13485 Remain Separate

  2. It’d be really nice if being ISO certified meant you were automatically compliant with FDA regulations. But since when is medical device compliance ever that simple? Certification and compliance are still two separate things, but the FDA/ISO 13485 harmonization should make it easier to accomplish both.

  3. The Quality Management System Regulation (QMSR)

  4. 21 CFR Part 820 is also known as the Quality System Regulation (QSR). After the FDA harmonizes with ISO 13485, the updated 21 CFR Part 820 will be known as the Quality Management System Regulation (QMSR). The FDA is planning on incorporating ISO 13485 “by reference” into the regulation.

  5. QSIT Will Change

  6. The QSR and the Quality System Inspection Technique (QSIT) go hand in hand. Some have understandably asked if changing to the QMSR will change QSIT. Short answer: yes. Long answer: “The current Quality System Inspection Technique will be reviewed and, as applicable, revised to incorporate the requirements of the rule, if finalized.” 1 Basically, we’re not sure what QSIT will look like after FDA’s ISO 13485 harmonization.

  7. Updates to ISO 13485 Could Complicate Things

  8. ISO standards are reviewed every five years. That doesn’t mean they’re changed in any substantial way, but they can be. FDA regulations change much less frequently. This has the potential to complicate harmonization efforts. Every time a new version of ISO 13485 is released, the FDA will need to review it and determine if changes are needed. Of course, if you’re already keeping up with an ISO certification, this wouldn’t really complicate things that much for you.

Prepare for FDA/ISO 13485 Harmonization

There are things you can do now to jump on this, even though the rule hasn’t been finalized yet. You don’t necessarily have to become ISO certified if you aren’t, but you should familiarize yourself with the standard. The proposed changes are on the FDA’s website, so you can begin looking at that. There are only a few areas with significant differences between Part 820 and ISO 13485, which are also outlined in the Federal Register.

In a more general sense, a good way to prepare is to make your business more flexible. And a good way to do that is to start digitizing your core quality processes so they can adjust quickly. This won’t just help with the harmonization, it’ll also help if there are more common changes due to more common updates to ISO 13485. Medical device compliance in general is easier when using an electronic quality management system to track all documentation and ensure proper training.

This isn’t the only quality management trend affecting medical devices. Familiarize yourself with the others by downloading our trend brief and learn how we can help you keep up.


Sources:

  1. "Medical Devices; Quality System Regulation Amendments,” U.S. Food and Drug Administration, Feb. 23, 2022.

2019-bl-author-sarah-beale

Sarah Beale is a content marketing specialist at MasterControl in Salt Lake City, where she writes white papers, web pages, and is a frequent contributor to the company’s blog, GxP Lifeline. Beale has been writing about the life sciences and health care for over five years. Prior to joining MasterControl she worked for a nutraceutical company in Salt Lake City and before that she worked for a third-party health care administrator in Chicago. She has a bachelor’s degree in English from Brigham Young University and a master’s degree in business administration from DeVry University.


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