The FDA planned a public workshop for mid-September to discuss the recently released draft guidance regarding regulation for mobile medical apps.
The guidance includes a fairly narrow subset of medical apps, covering those that are used as accessories to medical devices and those that transform a mobile platform into a regulated medical device.
“The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health, said in a prepared release announcing the availability of the guidance. “Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended.”
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
Several mobile medical programs have already passed FDA review for the U.S. market, including two consumer-friendly blood pressure cuffs that track and store blood pressure readings on smartphones (which won clearance in June), GE’s Pocket Viewer, Airstrip Technologies’ Airstrip, Mobisante’s MobiUs and MIM Software’s Mobile MIM.
The guidance outlined several categories of apps that won’t require oversight, including ones used solely to log or record information, ones that automate administrative duties like billing or inventory and programs that provide “copies” of medical texts.
The public workshop will be held from 8:00 a.m. to 6:00 p.m. on September 12 and from 8:00 a.m. to 1:00 p.m. on September 13 at the FDA White Oak Campus, and will also be webcast.
