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.

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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 BennetMcAuliffe: I wouldn't want a 'caretaker' in Kaine's Senate seat Tim Kaine backs call to boost funding for Israeli missile defense Bacteria found ahead of Olympics underscores need for congressional action for new antibiotics MORE (D-Colo.), Orrin HatchOrrin HatchTim Kaine backs call to boost funding for Israeli missile defense Froman: Too early to start trade talks with the UK Bacteria found ahead of Olympics underscores need for congressional action for new antibiotics 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 AlexanderGOP senators to donors: Stick with us regardless of Trump Overnight Healthcare: Mysterious new Zika case | Mental health bill in doubt | Teletraining to fight opioids Hopes dim for mental health deal MORE (R-Tenn.), Mark WarnerMark WarnerTim Kaine backs call to boost funding for Israeli missile defense Democratic National Convention event calendar Liberal group: Kaine could be 'disastrous' VP pick MORE (D-Va.) and Richard BurrRichard BurrThe Trail 2016: Putting the past behind them The Hill's 12:30 Report Burr pledges to retire after one more Senate term MORE (R-N.C.).