Thompson Quoted in Article About FDA Surveillance of App StoresGIGAOM August 31, 2010
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 about the FDA actively watching app stores for apps that it deems fill a medical purpose, with an eye toward regulating them.
Thompson said even smartphone apps require FDA approval, just like other medical "devices," and the determination if an app requires federal approval is strictly the FDA's call.
According to Thompson, it isn't clear which apps might trigger FDA scrutiny.
In an article that Thompson wrote in 2009, he noted the FDA could even regulate cell phones used for medical purposes. He pointed out that once a program is committed to computer media, "media with the code written on it is enough of a 'thing' for FDA to regulate."
According to Thompson, the FDA is actively engaged in surveillance of various app stores to see if apps should trigger their involvement. Applications where a smartphone is connected in any way to imaging are under scrutiny, in particular. Any app that is used to transmit images to a medical facility requires FDA approval.