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 stakes out exemptions to medical device premarket requirements."
Following is an excerpt:
The U.S. Food and Drug Administration has put mHealth innovation on the upward track by freeing dozens of mobile medical devices from increased regulation. A 12-page document issued on August 1 is part of the FDA's draft guidance for the regulation of mobile medical devices and apps. In this latest posting, the FDA has proposed that it will not require premarket submission requirements from certain Class I and II medical devices under the reserved criteria of section 501(I) of the Federal Food, Drug and Cosmetic Act of 2012.
The proposal is "a huge boost the to mHealth industry," said Bradley Merrill Thompson, an attorney for the Washington D.C. law firm of Epstein Becker Green and counsel for the mHealth Regulatory Coalition. It exempts a number of devices, such as thermometers, stethoscopes, talking first aid kits, hearing aids, fertility diagnostic devices and exercise equipment.
Thompson told mHealth News the categories targeted by the FDA are home to some of the newest mHealth innovations — like apps that turn cellphones into stethoscopes, or hearing aids and those that help users exercise — but they don't present a risk to the user, a key ingredient to the requirement for more stringent regulation.
The FDA "is being very practical and not wanting to apply regulatory requirements where the risks don't merit them," he said. "It also suggests that FDA is working hard to communicate more precisely to the whole industry, including the mHealth sector, its regulatory expectations."
