Senators ask for clarity on mobile medical apps

A bipartisan group of senators asked the Obama administration Wednesday whether additional legislation would ease its task in regulating mobile medical applications.

The group of six lawmakers praised the Food and Drug Administration for adopting a risk-based approach to governing the apps, and asked the agency to provide more details about its plans for rule-making.

The letter asked whether additional statutory definitions could help "clarify any uncertainty with respect to assigning risk level of medical software."

“While the FDA’s final guidance has provided clarity on the agency’s approach to regulation of mobile medical applications, we believe more transparency is needed to avoid stakeholder confusion over how a wider range of medical software might be appropriately regulated,” the senators wrote to FDA Commissioner Margaret Hamburg. 

The letter followed the publication of guidance for mobile medical apps in September. The FDA stated that its "tailored" approach to regulation will only apply to devices that are "intended to be used as an accessory to a regulated medical device, or transform a mobile platform into a regulated medical device."

The guidance assuaged some fears that the FDA would aim to regulate any health-related mobile apps as medical devices.

Wednesday's letter came from Sens. Michael BennetMichael BennetSenate poll raises Republican hopes in Pennsylvania, Florida Podesta floated Bill Gates, Bloomberg as possible Clinton VPs GOP Senate candidate reverses course, says he’ll vote Trump MORE (D-Colo.), Orrin HatchOrrin HatchGOP lawmakers ask IRS to explain M wasted on unusable email system GOP senators avoid Trump questions on rigged election Schumer says Pacific trade pact may have enough votes to pass the Senate MORE (R-Utah), Tom HarkinTom HarkinGrassley challenger no stranger to defying odds Clinton ally stands between Sanders and chairmanship dream Do candidates care about our health or just how much it costs? MORE (D-Iowa), Lamar AlexanderLamar AlexanderObama meets a crossroads for his healthcare law Music streamer Spotify joins Gillibrand’s push for paid family leave GOP senators avoid Trump questions on rigged election MORE (R-Tenn.), Mark WarnerMark WarnerPolicymakers face long road to financial technology regulation Liberal groups urge Schumer to reject Bayh for Banking gavel Why Yahoo's breach could turn the SEC into a cybersecurity tiger MORE (D-Va.) and Richard BurrRichard BurrPoll: Trump, Clinton in close race in North Carolina The Trail 2016: The grand finale Greens put M into NC Senate race MORE (R-N.C.).