Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg BNA Big Law Business, in “FDA Digital Health Program Not Broad Enough, Industry Says,” by Victoria Graham.
Following is an excerpt:
An FDA program to streamline the regulatory process for digital health technologies like wearable devices is set for expansion but may not be enough to aid innovation, regulatory attorneys who assist industry said.
Comprehensive protocols and practices are essential and desperately needed in the digital health world, but can regulation be produced quick enough as not to stifle future innovations? The attorneys are skeptical.
“Startups have been the lifeblood of the medical technology industry for decades,” Bradley Merrill Thompson, a health-care attorney at Epstein Becker & Green PC in Washington, told Bloomberg Law. Current regulatory frameworks have let many startups down, Thompson said, and the proposed pilot program expansion may not be able to relieve regulatory confusion fast enough. …
The FDA’s desire to improve the digital health technology pre-certification program is appreciated, Thompson said, but doesn’t address the most salient needs in the health tech space—establishing a firm understanding of which technologies are regulated and which are not.
“There are hundreds of companies out there with clinical decision support software, for example, who were expecting the FDA to define a risk-based line between what is regulated and what is not and the agency has completely let them down,” he said. Thompson is a member of the Bloomberg Law advisory board. …
This state of limbo, especially for entrepreneurs and startups without a structured compliance team, can create the risk of preventing innovative technologies from coming to market, Thompson said.