Bradley Merrill Thompson, a Member of the Health Care and Life Sciences practice in the Washington, DC office, was quoted in an article titled "FDA to Draft 'Straw Man' Mobile Health App Guidance with Industry Help."
Following is an excerpt:
FDA intends to release draft guidance on mobile health applications later this year to help gather feedback as it creates a more comprehensive mHealth regulatory policy, but not without industry input.
The mHealth Regulatory Coalition, led by Epstein Becker Green attorney Bradley Thompson, released on April 22 its suggestions on which intended use claims should trigger FDA regulation of a mobile health technology.
The industry group also offered in a March paper numerous representative examples of mobile health technologies categorized according to how it believes FDA should regulate them.
In addition to its suggestions on intended use claims, the mHealth Regulatory Coalition also plans to send FDA recommendations this month on mHealth policy related to accessory use in mobile health, and this summer on mHealth software guidance, Thompson told "The Gray Sheet."
Thompson is taking comments on the mHealth Regulatory Coalition's initial proposal, which is available for review at http://mhealthregulatorycoalition.org.
