Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice in the Washington, D.C., office was quoted in an article titled "mHealth Coalition Identifies Medical Device Threshold As Top FDA Question."
According to the article, a coalition of mobile health technology manufacturers, distributors, and users has pegged its top priority as identifying when a product — such as software, hardware or accessories — becomes a device and subject to FDA oversight, as both the agency and the group draft guidance to help regulate the emerging field. While the coalition has not developed recommendations on how to address mHealth, it suggests that FDA could consider the field in a similar manner to how dietary supplements are overseen, and says statutory changes are likely not necessary.
Thompson, general counsel of the mHealth Regulatory Coalition, said the key issues for the coalition involve the "threshold question" on the scope of FDA regulation, with the white paper specifically examining how to regulate the intended use, hardware accessories and role of software. He said the coalition plans to complete its draft guidance by April.
The white paper, called A Call for Clarity: Open Questions on the Scope of the FDA Regulation of mHealth, does not offer any specific solutions to the questions raised, as such recommendations will be covered in the next phase of the coalition's efforts, Thompson said. He noted that a copy of the white paper has been provided to FDA to consider as the agency works to develop its guidance.
Thompson said they are analogous because both involve transitions from treating disease to trying to ensure wellness. He said the FDA law wasn't written with that goal in mind, and its definitions and functions are focused on treating disease. "We are trying to kind of modernize the approach," he said. "We're really at an inflection point in the health of Americans ... rather than trying to treat people [with serious diseases], try to prevent it from ever coming about."
Thompson said the coalition is weighing whether a similar framework as was used to address supplements would be adequate for mHealth, but it's still too early to tell if that will be among the recommendations.
"One of the things we're thinking about is a process where you could go to FDA and ask them if certain associations are appropriate to make in labeling without triggering the medical device definition," he said.
Thompson said guidance is sufficient to address mHealth, and no statutory changes are needed. "Right now, I'm optimistic that it can all be done by guidance," he said. "I haven't run into any part of the (Food, Drug, and Cosmetic) Act which presents any sort of insurmountable barrier that we have to overcome through legislation." Nevertheless, he said rulemaking may be necessary on classification for certain hardware or software accessories.
