Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in The Verge, in “The FDA Doesn’t Want to Regulate Wearables, and Device Makers Want to Keep It That Way,” by Colin Lecher.
Following is an excerpt:
The FDA is making the guidance at a time when the wearable tech is already a cycle years in the making. "The right time [to make the guidance] would've been five years ago," says Bradley Merrill Thompson, a member of the firm at Epstein Becker & Green who focuses on medical device regulation. …
The FDA, then, is working a balancing act: craft a policy detailed enough to offer guidance, but broad enough to give itself latitude. "It's hard to put in that precision without putting handcuffs on yourself," Thompson says.