FDA wellness clarifications helpful, accessory proposal is just a start

By Brian Dolan
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Brad Bradley Merrill Thompson

At the end of last week the FDA posted two draft guidance documents related to digital health. One focused on clarifying the line (PDF) between a general wellness device or app and a regulated medical device. The other intended to help clarify when an "accessory" device (PDF) to a regulated medical device, like a companion smartphone app, for example, would also fall under the agency's purview and be regulated as a medical device.

The first draft guidance document was fairly straight forward -- we summarized it here.

Bradley Merrill Thompson, who has written extensively about mobile health regulation for MobiHealthNews over the years, sent us his initial analysis of the documents. Thompson recently served on the FDASIA workgroup, which suggested the FDA include many of the clarifications it ended up publishing in the draft guidance on wellness devices. Here are a few of the things Thompson and his colleagues asked of the FDA, and how they delivered:

We need rules not just examples: "FDA responded by including clear rules on page 3 and 4 of the draft guidance. FDA also included a very helpful algorithm on page eight of the draft guidance. I love the algorithm." 

Don't claim jurisdiction over every product that identifies a disease and consider "general recognition": "That’s exactly what FDA proposes to do. No longer does the mere mention of a disease in promotional materials mean that FDA may regulate it. FDA has chosen to draw a very common sense line that avoids regulating products that help people manage common chronic diseases. Those are incredibly important extensions of FDA’s policy of enforcement discretion. And indeed, FDA chose to recognize the food and drug law principle of general recognition itself, and the value of reviewing peer-reviewed literature to establish accepted scientific truths."

Don't just offer guidance on devices that claim prevention, include some for those that manage specific conditions, too: "FDA agreed, and specifically extended the wellness category to not just disease avoidance, but those devices which may help living with chronic diseases. This is where they invoked our proposed concept of generally accepted science discussed above. FDA further agreed with our comments that it would be useful to focus on those products used for tracking and trending health information for the purpose of influencing lifestyle decisions. As we suggested, FDA draws the line at those products that are invasive."

The other proposed guidance from the FDA is a bit more difficult to parse, but any potential changes to the accessory rule should be of interest to digital health companies wondering about their regulatory status.

"This guidance, in contrast to the wellness guidance, is very difficult to read quickly because the subject is so technical, so even very minor wording issues can have profound impact," Thompson explains. "I’m also a little less in love with this guidance document, in that it does not go as far as I’d like to see. Basically it doesn’t solve the problem, but instead suggests that industry solve the problem itself."

Based on the proposed guidance document: "FDA agrees that accessories do not always need to be regulated the same as the parent, and FDA has come up with a reasonable definition of an accessory [which was lacking before]. Those were clearly the first two steps, and we are pleased with FDA’s response," Thompson wrote.

Thompson explained that the FDA wants companies who believe their accessory devices shouldn't be classified to the same degree as the parent device to submit them as "de novo" devices to help create new classifications and pathways for future products like them. Thompson writes:

"Unfortunately, as often happens in this world, the whole issue seems to have come down to money. FDA does not want to shoulder the burden unilaterally to reclassify these accessories. They want industry to put together submissions that include all of the data necessary to support the reclassification. I understand that, but in the real world, many companies hate the de novo classification process for a very simple reason. In the de novo process, the company has to be magnanimous in the sense that it has to pursue de novo classification at pretty significant cost, only to blaze the trail for its competitors to follow. The whole de novo process is predicated on one company preparing a pretty substantial submission seeking a lower classification. Once that classification is lowered, then competitors can act as free riders and get their products on the market at a whole lot less expense. In the real world, there are not many companies that want to help competitors in that manner."

The FDA is taking comments from the public for a 90-period, starting when the documents were posted last week.