The medical device industry has been anticipating harmonziation between FDA’s quality regulation requirements and the international consensus standard for medical device quality for years. Now, it appears the regulatory body is moving forward with these efforts.

On Feb. 23, FDA published a proposed rule intended to harmonize its quality regulation requirements with the international consensus standard for medical devices manufacturers (ISO 13485:2016). The proposed rule is now open for public comments at www.Regulations.gov under docket number (FDA-2021-N-0507). The new rule would replace the Quality System Regulation (QSR), at 21 C.F.R. Part 820, with a newly named Quality Management System Regulation (QMSR).

Greenlight Guru hosted an insightful panel discussion about the quality regulation proposal this week on the firm’s Global Medical Device Podcast. Here are five of our favorite takeaways from the episode.

Is True Global Harmonization of Quality Regulations Even Possible?

“…We have different government agencies in various parts of the world that are obviously trying to make sure that the laws and the regulations are there to protect their citizens,” Jon Speer, Greenlight Guru’s founder said. “So, can we ever get to a point where there’s true harmonization? And if we did, would we be better off? These are some open-ended questions that are in my mind.”

Mike Drues, president of Vascular Sciences, made an interesting point about how the conversation of global harmonization from a medical device regulations perspective has shifted now with this proposed rule.

“In the past, global harmonization has always been in the context of the regulatory system. In other words, why does it make sense to have to jump through different regulatory hoops … why can’t we have one global regulatory framework that everybody jumps through and if you meet those requirements you can sell your medical device anywhere in the world,” Drues said. “What we’re talking about today is the quality equivalent of global harmonization for the regulatory system.”

The More Things Change, the More They Stay the Same

“I kind of felt like a kid waiting for the next Star Wars to come out, I’ve been waiting for this proposed rule to come out for so long,” said George Zack, principal and co-founder at Two Harbors Consulting. “I was like ‘Okay, great. Darth Vader is Luke’s father, what are we going to get with this proposed thing?’ And I was expecting this big rewrite of [21 CFR Part 820] and frankly, it seemed like more of a gap-bridging measure.”

Still, he said that he does believe it is a necessary step toward global harmonization between FDA’s quality regulations and the international standards.

“If you’re already compliant, I don’t think it’s a huge lift to shift to some of these considerations,” he said.

If This Is Your First Time Hearing About ISO: 13485:2016

Etienne Nichols, a medical device guru at Greenlight Guru and co-host of the podcast, asked the guests about the potential pros and cons of the proposed rule for, say, a smaller domestic medical device company that is looking at ISO 13485 for the first time. Drues didn’t pull any punches on that one.

“If there’s a company that’s doing business only in the United States and this is the first time that they’re looking at 13485, I would argue that that’s indicative of a much bigger problem than anything we’re talking about here. … If somebody doesn’t know about this particular standard, whether it’s required or not, that is a problem.”

An FDA Inspection Feels Like Being Tailed by the Police

“Have you ever been driving and all of a sudden a police car shows up right behind you? You change — well at least, I change,” Speer said. “I wasn’t doing anything wrong, I don’t think, but all of a sudden my hands are at 10 and 2, and I’m like, ‘is everybody buckled?’ To me, that’s kind of like what it feels like to go through an FDA inspection.”

An ISO audit, on the other hand, feels more relaxed. Speer used the example of being able to offer the ISO auditor a cup of coffee or invite them to lunch with the team. You can’t do that with an FDA inspector, he said, because it might be misconstrued as a bribe.

Skip the Preambles (We Won’t Tell)

Sitting down to read a 52-page document on quality regulations can be daunting to say the least. Luckily, if your job requires you to familiarize yourself with FDA’s new quality management systems regulation proposal, Zack shared a pro tip that will save you time.

“You probably can trim 30 pages out of that reading because there’s a lot of preamble stuff … things that are less relevant than the rule itself.”

Article source: Qmed