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 about proposing that FDA regulate mHealth accessory products.
Following is an excerpt:
A coalition of mobile health technology stakeholders is proposing FDA regulate mHealth accessory products akin to the way the agency previously said it would oversee them for medical device data systems, with the group also contending that the de novo review process for novel devices could play a significant role in regulating these emerging products.
The mHealth Regulatory Coalition -- which consists of developers and users -- released draft guidance it plans to propose to FDA on classifying mHealth accessory productslast week, following a guide the coalition released late last month on when intended uses bring these technologies under FDA's purview and when they would not be regulated by the agency. A third proposed guidance is expected to be released later in the summer to address regulation of mHealth software applications.
"That's really how FDA intended it -- they intended it to be the first building block but for others to come," said Bradley Merrill Thompson, general counsel of the mHealth Regulatory Coalition, on the MDDS rule's applicability. "We're trying to flesh out what that looks like, but we're also trying to take principles that we see from that document and apply those principles more generally."
Thompson added the review pathway for novel products appears to be tailor-made for mHealth, as it is used in cases where devices take "a different approach technologically than FDA has seen before, but the ultimate medical purpose is reasonably benign," he said.
For example, the guidance proposes that a software application on a phone that takes manually-entered wellness information, such as on exercise or calorie intake, and is marketed as a way to reduce the risk of developing diabetes should not be deemed a medical device, Thompson said. However, such a device currently is considered one because of its reference to a specific disease, he added. "We don't think that the mere mention of something like diabetes and the promotion of that should cause it to be regulated," he said, noting that it would fit the category outlined in the coalition's proposed guidance on socially beneficial and low risk devices.
However, Thompson added that a device that took blood glucose meter readings directly from a medical device should be regulated, as it is a diabetes management system.
