MedTech Education

In this episode of MedTech Crossroads, host and in2being Managing Director Gene Parunak fields a question about the difference between International Organization for Standardization (ISO) standard 13485, which covers quality management systems for medical devices, and the Food and Drug Administration’s (FDA’s) quality system regulation (QSR) codified in Part 820 of Title 21 of the Code of Federal Regulations (21 CFR 820).

The question is twofold:

  1. What are the differences between ISO 13845 and 21 CFR 820?
  2. Can a medical device manufacturer safely use a manufacturer who already complies with quality management systems similar to ISO 13845 for their medical device production?

What Are the Differences Between ISO 13845 and 21 CFR 820?

ISO 13845 is a consensus international standard. Many international agencies use it to regulate the manufacture of medical devices. The FDA’s quality system regulation, 21 CFR 820, fills the same function and bears many similarities to ISO 13845 but is not the same.

“We see a lot of companies get tripped up because they say, ‘Oh, I need somebody who’s 13485 registered to build my product in the U.S.,” says Parunak. “And the answer is, ‘No, you don’t.’ Is it useful? Yes, it can be, but does it cover you for quality systems? No, it doesn’t.”

In other words, just because a manufacturing facility is ISO 13485 certified does not mean it meets all the requirements of 21 CFR 820. The owner of a medical device is responsible for ensuring their product fulfills the FDA’s QSR, even if the device is manufactured in an ISO 13485–certified facility.

The FDA is interested in and actively working on harmonizing 21 CFR 820 with ISO 13485, but the process is lengthy because the FDA’s QSR is ensconced in U.S. law; the QSR is not a factor that the FDA can arbitrarily change. In February 2022, the FDA proposed a new rule that would align the U.S. QSR with ISO 13485, but the rule has not yet been finalized.

Can a Medical Device Manufacturer Safely Use a Manufacturer Who Complies with ISO 13485 for Producing Their Devices?

Regarding the second question, Parunak warned, “You can actually get into a lot of danger if you too closely harmonize your systems.” For example, some automotive components require quality systems very similar to those used for medical devices. The problem with combining systems is that FDA auditors are likely to be confused if your medical device manufacturing procedures reference procedures for building automotive components. In such cases, FDA auditors will likely require you to provide clarification.

Are you endeavoring to bring a new medical device to market?  in2being can help you with all aspects of the development process, from prototyping and laboratory testing to manufacturing and FDA compliance.

To learn more about our services, contact us today.

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