4 min reading time

Group member Roger Cepeda wrote an informative (and cleverly worded) piece at https://medgroup.biz/RWE called “FDA’s Guidance on Real-World Evidence for Medical Devices: Great for Class III Registry Participants, But What About the Rest of MedTech?”

Due to space limitations, I can only summarize and encourage you to read it.

Why did FDA write the guidance? Presumably to respond to the 21st Century Cures Act requires FDA to consider real-world evidence (RWE) and to show FDA is saying data generated outside of clinical trials can still be valid data… as long as “the real-world data (RWD) is of appropriate quality.”

So what constitutes “appropriate quality?”

• One example: The Cath-PCI Registry, one of eight hospital-based registries managed by the American College of Cardiology as a type of Real-World Data that “might provide sufficient evidentiary support” for expanded labeling (indications for use), “depending on the specific devices, indications, and analyses.”

• Another: If a Class II or III manufacturer generates post-market surveillance reports, and under certain circumstances see (https://medgroup.biz/RWE), the data collected in collaboration with a medical society to create a registry “could support future premarket submissions.”

Roger shares four other examples including one that helps bring a device to market earlier.

After reading the piece, I’ll be interested in comments explaining what the guidance means for your company. Or let us know if you interpret the guidance differently than Roger did.

Thanks, Roger.

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Make it a great week.

Joe Hage
Medical Devices Group Leader

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Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Julie’s the best. Thank you for so consistently contributing to our discussions.

Julie Omohundro
Principal Consultant at Class Three, LLC
Maybe marketing, indeed. I’m thinking maybe FDA is touting this and some other relatively modest achievements in an effort to make voters think they getting something for their effort in showing up at the polls for the last election?

Julie Omohundro
Principal Consultant at Class Three, LLC
And it was highlighted in a session at the MDIC annual meeting today, lol.

Julie Omohundro
Principal Consultant at Class Three, LLC
Roger, there was also a special panel presentation on the topic at the IMDRF Stakeholders meeting.

Julie Omohundro
Principal Consultant at Class Three, LLC
Joe, thanks. It’s pretty much the only LI forum I’ve found useful, so I’m happy to contribute when I can.

Julie Omohundro
Principal Consultant at Class Three, LLC
“Shuren acknowledges that many companies launch first in Europe and then in the US, and this story justifies at least some hope that the day may come when American device-makers choose to launch first in the US when American patients represent the largest potential market segment.”

I think the EU first phenomenon is a good bit overstated. A study published in the BMJ last year looked at 206 devices approved in both the US and EU and found that almost 40% were approved or cleared in the US first. I think it was a pretty bad study, but I also think these numbers are probably not wildly off the mark. In any case, at this point, I think Shuren is probably now in the role of a rainmaker when the rain is coming soon, no matter what he does or doesn’t do. Whether he thinks so too, I would love to know, but never will.

Julie Omohundro
Principal Consultant at Class Three, LLC
Interesting perspective on this guidance. Trying to figure out why FDA does…anything…is a perpetual source of entertainment. I don’t really have a handle on this one, but I have been inclined to think it was one of those guidances addressing a subject on which FDA had received unrelenting pressure, so it finally issued a guidance to put an end to it, without really giving much away. The possibility that it might be intended a stepping stone to a drug guidance hadn’t occurred to me, but it’s as good an explanation as any.

Julie Omohundro
Principal Consultant at Class Three, LLC
“For those of you who have worked on similar medical device press releases, can you name a time in which the FDA issued its own statement, touting your product’s approval, nine days after you issued your press release? Now that’s progressive.” I’m not clear on the point here? FDA frequently issues press releases touting new approvals.

Laura Nobles
Healthcare marketing and PR expert/Agency Owner
Thanks, Joe! This is also a hot topic at The MedTech Meeting this week…

Roger Cepeda, JD, MBA, RAC
Medical Device and Biotech Attorney
Julie- thanks for your insight. I agree with you that the RWE guidance was likely in response to “unrelenting pressure,” and, in the FDA’s recent Fall Regulatory Education for Industry conference that ended yesterday, almost every medical device track FDA speaker mentioned the RWE guidance without saying anything substantive about it, almost like a marketing plug.

Roger Cepeda, JD, MBA, RAC
Medical Device and Biotech Attorney
On October 10th, FDA is holding a free webinar on this topic/guidance. https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm574232.htm
While it’s consistently presented as an issue of interest for the entire medical device industry, I’m waiting for an example or idea that isn’t related to a Class III registry. Roughly speaking (and others please correct me if I’m mistaken), the FDA sees about 50 Class III/PMA submissions and close to 4000 Class II/510(k) per year.

Dave Gaisser
Quality and Regulatory Consultant, Geyser Medical Consulting
Thanks, Joe, to both you and Roger for the summaries. Roger’s interpretation makes it easier to get a grip on what FDA might be thinking. It would be nice if they were trying to be more helpful; might make things a little easier for some smaller or new manufacturers, assuming they can access existing RWD or develop their own.