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 "mHealth Experts Praise FDA's 'Expansive' Mobile App Regulations."
Following is an excerpt:
mHealth advocates are giving good early reviews to the U.S. Food and Drug Administration's final guidance document on the regulation of mobile medical apps, with one expert calling it "an expansive document that truly seeks to deregulate our nimble and innovative industry, while ensuring patient safety." ?...
We are obviously delighted that after all of the debate this summer, FDA chose to go forward with publishing the guidance," said Bradley Merrill Thompson, an attorney with the Washington D.C.-based Epstein Becker Green law firm and legal counsel for the mHealth Regulatory Coalition. "I think this shows both courage and a genuine desire to help innovation." ?...
Thompson also had some specific comments about the final guidance:
The FDA, he said, "took the concept of exempting borderline apps under its enforcement discretion authority, and greatly expanded the amount of text dedicated to explaining its approach," going from a footnote to six full pages. "This is a wonderful development for (the) industry because it really is clarifying what was previously confusing, and perhaps even expanding on the idea. Plainly there are a lot of apps that in FDA's mind might qualify as a medical device but don't deserve active regulatory oversight."
Thompson also took note of the FDA's decision to answer public questions on mobile app regulation. "Perhaps the best news of the day is that this document won't be simply static guidance," he said. "This is incredibly important, because the mobile app world is changing so quickly that this notice and comment style of guidance development could not possibly keep up. Now obviously there might be an issue if FDA were to take a conservative view of what gets regulated, but every indication now is that FDA is trying to be as deregulatory as they can be, while still assuring patient safety."
On the issue of clinical decision support software, which was "given little attention in the final guidance by design," Thompson said the FDA will work with the FCC and ONC as a part of the FDASIA section 618 process, and come up with some sort of proposal in January 2014. "The proposal might be a part of the formal report to Congress, or it might be separate. The proposal might be specific, or it might identify a range of issues," he said. "But in any event FDA indicated a clear intention to solicit further input after the first of the year when they have completed the agency discussions."
