FDA Center for Devices and Radiological Health

And neither of those are typical outcomes measures for a clinical trial.

So back, I'll be off by a few years, but a decade ago, CDRH, that is FDA Center for Devices and Radiologic Health, began to describe the ability for folks outside of the FDA to form what are known as collaborative communities.

And those are very formally chartered entities that exist in a pre-competitive space, which allow academic scientists and representatives from multiple medical device companies and people with lived experience in The case of the Implantable Brain Computer Interface Collaborative Community, the IBCICC, people with lived experience of paralysis and patient support groups and care partners and others all have a carefully regulated forum where we can have discussions with members of regulatory agencies such as FDA.

And usually those conversations between a company and FDA are correctly held in private because there's all kinds of proprietary information that's being exchanged and that system works the way that it should.

And before we start getting into specific topics, Sean, I just want to explain what the differences are between these different categories.

So starting out with the A list, as you can probably guess, this is the priority guidance document list, and I'm using the word priority in air quotes here, that CDRH intends to publish.

uh during fiscal year 2027 and remember sean uh or notice that fda is parsing their words very very carefully here they're not saying that they will publish these things on the a-list they say they intend to publish Sometimes it's frustrating when FDA doesn't make a definitive statement, a definitive commitment that, yes, we are going to do this.

It's kind of like, Sean, this might be sort of a silly example, but imagine that, God forbid, your house is on fire.

and the firemen come to your house, and the fire chief tells you, we intend to put out the fire, as opposed to we will put out the fire.

Anyway, so that's the A list.

The B list are guidance documents that CDRH intends to publish as resources permit during fiscal year 2027.

And we all know, Sean, We've talked about this before, what a shit show it's been at FDA for the last several years.

Okay.

Do you want to talk about CDRH Learn? Yeah.

How dare you?

Yeah, how dare you? First of all, you didn't even scoop me.

The

CDRH

website, CDRH Learn has always been a great resource for just anything from like getting introduced to how things are regulated the whole way through like special topics.

It's where FDA posts all their webinars and workshops and things like that.

He's a partner at Arnold and Porter.

He served two decades at CDRH, Center for Devices and Radiological Health at FDA.

He was the CDRH Associate Director for Policy, and he's obviously been a major player in the development of policies for some time in the medical devices area.

So welcome back to FDA Watch, Phil.

Good to see you again.

Appreciate you having me on today.

Sean Boyd is corporate vice president at Quality Hub.

He also is a CDRH veteran, served 31 years at the agency.

Yeah, I think, let me give a big shout out quickly to the FDA.

You know, sometimes they take a lot of grief, but my experience over my years with CDRH in particular, which is the medical device division of the FDA, they have been incredibly helpful.

We're part of a new pilot program that the FDA has in store called the TAP program, which allows us to have some quicker reviews and to meet with our review teams.

We have already done and have, you know, since the time of our feasibility work, compassionate use cases.

And it is also being used to give supplemental or primary evidence for especially labeling expansions these days as well.

And of course, you witnessed this as chief epidemiologist at CDRH.

Corey, what's your perspective on how that's evolved over the last period of time?

Yeah, thanks, Wayne, for the question.

and capture of unique device identifier information or UDI at the point of care can still be very limited.

And so identifying device data is often the first hurdle that we encounter.

When CDRH released their 2025 guidance for use of real-world evidence to support regulatory decision-making for medical devices, they specifically list real-world data sources, including EHRs, claims, registries, charge master and billing data, and device data repositories.

But two additional categories that are mentioned that I think are worth highlighting are patient and device-generated data.

That is exactly right.

The document specifically notes that CDRH does not evaluate information related to contract liability warranties, And that FDA's issuance of a substantial equivalence determination does not mean the FDA has made a determination that the device complies with other requirements of the act.

For companies building AI, the big takeaway from this document is how Bunker Hill Health navigated the transition from non-contrast to contrast imaging.

They changed their output from agonist in categories to a continuous volume metric in millimeters cubed.