A Tennessee congresswoman has filed a bill designed to better explain which mobile medical apps fall under FDA regulatory responsibility. Regulators attempted to establish those boundaries with new guidance announced in late September.
The Memphis Business Journal reports that Rep. Marsha Blackburn (R-Brentwood) has already signed on two additional Republican and three Democratic sponsors. Essentially, the bill will codify higher-risk and lower-risk mobile apps, with the former group being the only one to require FDA regulation.
According to the article, the bill (H.R. 3303) would define a higher-risk mobile medical app as one that interacts with pacemakers and other implanted devices. But apps that track blood pressure, calories or other benign medical data would qualify as lower-risk.
Blackburn told the newspaper that the goal is to encourage innovation by establishing solid legal guidelines to prevent mobile medical app makers from going through the regulatory process if their product isn't invasive or doesn't carry a high health risk.
In late September, after years of public hearings and debate, the FDA unveiled final rules designed to guide companies developing mobile medical apps. Regulators will exert oversight over apps designed to work with a regulated medical device, or turn a smartphone/tablet into a de facto medical device. But wellness devices such as pedometers or heart-rate monitors are off the hook. Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, explained to Reuters at the time that the guidance asserts regulatory oversight depending on function and risk.
Regulators initially issued draft guidance in July 2011 and processed more than 130 comments over the subsequent two years.
- read the full Memphis Business Journal story
- for more on the bill