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 “Telemedicine: FDA Will Not Regulate Consumers’ Mobile Devices, Official Tells Panel.”
Following is an excerpt:
The Food and Drug Administration has no plans to regulate consumer smartphones and tablet computers as medical devices, an agency official told the House Energy and Commerce Oversight and Investigations Subcommittee March 21.
Neither would FDA consider mobile platform manufacturers or medical apps distributors—such as the iTunes App store or the Android market—to be medical device manufacturers, FDA’s Office of Device Evaluation Director Christy Foreman said on the third consecutive day of Energy and Commerce subcommittee hearings on oversight of the mobile medical applications industry. ?…
FDA issued draft guidance on mobile medical apps in July 2011, and House Energy and Commerce Republicans as well as the mobile health industry have pressed the agency to release the guidance soon in final form. ?…
Attorney Bradley Merrill Thompson, with Epstein Becker & Green, PC in Washington, told BNA that many in the industry had hoped FDA would say the issuance of the final guidance was imminent, but acknowledged the lengthy approval process for such documents. Thompson also helps lead the mHealth Regulatory Coalition, which has advised FDA on how it believes the mobile apps market should be regulated.
Nevertheless, he said the hearings likely put pressure on the agency to publish the guidance sooner rather than later.
Thompson also commented that FDA appeared to be “doing all they can do to minimize the impact of the tax,” noting that FDA is narrowly targeting its enforcement authority and that many products would be exempt regardless from the tax under ACA.
He also noted that manufacturers should welcome FDA’s approach on limiting oversight based on intended use of products, not actual use.
“This has been a very hot topic in the off-label promotion debate—whether FDA can use actual use to infer a manufacturer’s intended use,” Thompson said. “In the past, FDA and other government enforcers have been much more aggressive on this point. They appear to be standing down.”
He also said statistics cited by Foreman and in the FDA letter that currently regulated mobile apps were being cleared, on average, within 67 days were surprising, because of some industry reports that some apps had “really been put through the ringer.” Thompson also testified for the mHealth coalition at the March 19 hearing.