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 Forum Explores Regulation of Mobile Medical Apps.”
Following is an excerpt:
How should the U.S. Food and Drug Administration (FDA) regulate mobile medical apps? More than 20 experts shared their opinions with the FDA on September 12, the first day of a two-day public forum in the agency’s Rockville, MD, headquarters.
Nobody disagreed that the FDA should regulate mobile medical apps used specifically for diagnostic or clinical treatment purposes. But for apps in which the use might not be clearly defined, apps that are accessories to other medical devices, and accessories supporting medical apps, the opinions that were expressed reflected controversy and concern.
Mobile devices and the medical apps that support them represent a technology explosion, sure to make a revolutionary change in healthcare delivery. The crux is how the FDA can keep up with mobile developments, protecting patients from potential harms without stifling innovation and R&D investment.
In mid-July, the agency published a draft guidance documenton its proposed regulatory approach, and the agency is soliciting comment through October 19, 2011. The document defines mobile medical applications designed for mobile computing devices and smart phones that the FDA intends to regulate, and delineates mobile medical applications that affect or could affect the performance or functionality of currently regulated medical devices.
Monday’s meeting was designed to give industry and experts the opportunity to comment on the agency’s direction.
The first two panels included representatives from nonprofit organizations promoting Web-delivered patient education content and innovations to lower the cost of healthcare, as well as a consulting firm specializing in global medical device regulatory requirements, a venture capital firm, mobile apps developers, and hardware vendors. All emphasized that the potential for mobile apps to change the healthcare world is enormous.
Attorney Bradley M. Thompson, a partner of the law firm Epstein Becker Green, suggested that when it comes to regulating accessories, the clearest, cleanest way is to classify them. He suggested that there be a specific classification, however broad, based on functionality rather than the uniqueness of what the mobile app does.
“This would free up and avoid overregulation, even with the rules proposed by different tiering,” Thompson said. Manufacturers would have an obligation to have proof of functionality needed for a specific classification.