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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 Farrand BennetGOP Senate candidate fundraising lags behind Dems in key races Dem shutdown strategy: Force McConnell to deal DACA is neither bipartisan nor in America's interest MORE (D-Colo.), Orrin HatchOrrin Grant HatchOvernight Tech: Uber exec says 'no justification' for covering up hack | Apple considers battery rebates | Regulators talk bitcoin | SpaceX launches world's most powerful rocket Overnight Cybersecurity: Tillerson proposes new cyber bureau at State | Senate bill would clarify cross-border data rules | Uber exec says 'no justification' for covering up breach Hatch introduces bipartisan bill to clarify cross-border data policies MORE (R-Utah), Tom HarkinThomas (Tom) Richard HarkinOrrin Hatch, ‘a tough old bird,’ got a lot done in the Senate Democrats are all talk when it comes to DC statehood The Hill's 12:30 Report MORE (D-Iowa), Lamar AlexanderAndrew (Lamar) Lamar AlexanderSanders wants pharma CEOs to testify on opioid crisis Trump expects us to trade clean air and water for updated infrastructure House GOP warming to ObamaCare fix MORE (R-Tenn.), Mark WarnerMark Robert WarnerRegulators push for 'coordinated' approach to bitcoin trading House funding bill includes bipartisan Medicare reforms Overnight Tech: Mulvaney reportedly froze Equifax hack probe | Dems want new restrictions on Comcast-NBC | NJ gov signs net neutrality order | Senate confirms patent chief MORE (D-Va.) and Richard BurrRichard Mauze BurrOvernight Cybersecurity: Trump poised to allow release of intel memo | GOP chair threatens to subpoena DHS over Kaspersky docs | Pompeo defends meeting Russian spy chief Furor grows over Nunes intel memo Pelosi calls on Ryan to oust Nunes over ‘bogus’ memo MORE (R-N.C.).