Bradley Merrill Thompson Quoted in Article, “FDA Reiterates Intention to Regulate Only a Small Portion of Mobile Medical Apps”

The Gray Sheet

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "FDA Reiterates Intention to Regulate Only a Small Portion of Mobile Medical Apps."

Following is an excerpt:

On the last day of hearings by three House Energy and Commerce subcommittees March 19-21, CDRH Office of Device Evaluation Director Christy Foreman largely reiterated FDA's previously stated approach to regulating mobile medical apps. Meanwhile, Energy and Commerce Committee Vice Chair Marsha Blackburn, R-Tenn., hinted at legislation on the issue. ?...

The March 19-21 hearings before three separate subcommittees of the House Energy and Commerce Committee — the Communications and Technology Subcommittee, the Health Subcommittee, and the Oversight and Investigations Subcommittee, respectively -- centered on FDA's approach to regulating mobile medical apps, and whether that approach might unduly delay innovation by exposing apps to the medical device excise tax, or by overregulating or spreading uncertainty among developers. ?...

Bradley Thompson, general counsel for the mHealth Regulatory Coalition, said that as a "nerdy lawyer" he could appreciate why FDA has taken so long to finalize the guidance. He speculated that perhaps the agency is delaying because it wants a more definitive decision on where to draw the regulatory line in the constantly evolving mHealth world. "I think what they need to do is put something out there, and update the guidance periodically," Thompson testified. He also suggested that FDA create a website to offer guidance on a real-time basis. ?...

On March 19, Thompson argued that FDA needs consistent enforcement. He described a urinalysis app that promises to read the results of a dipstick test by using the camera on a cell phone. While acknowledging the promise of such technology, he stressed the importance of FDA ensuring a level playing field by subjecting the app to the same manufacturing quality system requirements as apply to a traditional urinalysis instrument.