FDA Digital Health Program Not Broad Enough, Industry Says

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 ...