Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled “FDA Mobile Apps Workshop: When Is a Car a Medical Device Accessory?“
Following is an excerpt:
How and when should the FDA regulate mobile medical apps that act as accessories to medical devices? When should it not regulate them at all? Those questions were taken up in a midday panel discussion on day one of FDA’s Sept. 12 and 13 workshop on its draft guidance for mobile medical device applications.
“Traditionally an accessory just physically connects to a medical device,” said moderator Bryan Benesch, a consumer safety officer in FDA’s Center for Devices and Radiological Health, to kick off the conversation. “There may be situations where you have many products tied in a string until it ultimately gets to the device. And that’s not a situation that we generally see or regulate. So I want the panel members to tell us what they think the future will bring in the next few years regarding what we should consider an accessory.”
Before turning over the mic to the panel, Benesch cited an example: a prototype system carmaker Ford is testing that can tell diabetics on the road when to inject insulin. “That’s an interesting platform that we might need to consider,” he said.
Bradley Merrill Thompson began by extending a fundamental question taken up in an earlier workshop session: What makes a product a medical device accessory?
“It all comes down to three things. Words: How do I describe it? Actions: How do I position it in the marketplace? And knowledge: What do I know about how it’s being used in the marketplace? All those things together form intended use,” said Thompson. “Don’t confuse use—how a thing is actually used—with intended use, because intended use is the concept that decides whether or not it gets regulated. What does the manufacturer, the one selling the thing, intend it to be used for? If I intend for it to be a tongue depressor, it gets regulated that way. If I intend it to be a popsicle stick, it gets regulated that way.”
Thompson then turned to the Ford example. “If they go out on a marketing campaign to say, ‘This car will improve your health because it can be used to deliver care through devices you can add to it,’ they have made it a regulated accessory medical device to whatever parent devices then get put in that car pursuant to their promotion.”
In such cases, determining medical device accessory vs. non-medical device accessory requires a little digging, added Thompson. “It’s words; it’s deeds,” he said. “What design features are in it? Do they go into that car and create a power system that somehow is uniquely capable of supporting medical devices? Do they use other elements of the computer technology with protocols that make it uniquely suitable for medical devices? What have they done to tailor it? What standards do they declare conformance to? If they’re declaring conformance to certain medical standards that serve no other purpose other than delivering medical care through a medical device, what does that say about their intent for that car?”
These are “very complicated issues,” concluded Thompson. Before anyone can know whether to regulate an “accessory,” or how, “we need to get to the level of ‘What are they doing to promote it and what are they saying about it'”