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 Modern Healthcare, in “FDA Issues First Approval for Remote Continuous-Glucose-Monitoring App,” by Darius Tahir.
Following is an excerpt:
The approval likely has wider regulatory implications for the other medical apps and devices as well, suggested Bradley Thompson, a lawyer with Epstein Becker Green and an expert in mobile health regulations.
The agency approved the app through the so-called “de novo” pathway, which allows companies to face lightened regulatory requirements for novel, yet low- or medium-risk devices or software. That's significant, Thompson said, because the app is acting as an accessory to a high-risk device—a continuous glucose monitoring system. …
“Industry remains concerned that this is a relatively inefficient way to deal with a very broad accessory issue where similar technologies might be very low risk but may connect to a different medical device,” Thompson said. “Dexcom had to undertake undoubtedly considerable expense to put together the de novo submission, and my hat is off to Dexcom for basically blazing the way for its direct competitors to follow. Unfortunately, not many companies are so willing to subsidize their competitors.”
