The agency should offer more clarification on its "intended use" guidelines for regulating devices and on its definition of accessories, said Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition and a partner with Epstein Becker & Green in Washington.
Speaking at the Fourth Annual mHealth World Congress, Thompson said "there are lines you can't cross when dealing with the FDA." Regulation of a product depends on how it is promoted, Thompson said. If a company claims its product promotes health, it is subject to regulation; if it claims the product promotes wellness, it is not, he said.
Thompson said that a manufacturer of exercise equipment would be "clearly outside of FDA jurisdiction" if it promoted its product as improving overall health and physical conditioning, but that it would be "clearly within FDA jurisdiction" if it used the equipment to diagnose or treat heart disease, stroke, obesity, diabetes, or peripheral artery disease. ...
Thompson added that some firms seek FDA regulation of their products in order to strengthen their reimbursement strategy. If a company can show that its product is related to fighting disease, it can more easily argue that it should be reimbursable by insurers, he said.
FDA is choosing not to regulate electronic health records as devices, Thompson said. In many cases EHR are used for the "passive holding of data for professionals." But when people add functionality—analytics or algorithms—"that's muddying the waters," he commented.