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 BennetSenate Dem: No clarity, 'little competence' behind travel ban Dems step up attacks on GOP ObamaCare bill Trump welcomes Gorsuch on first Supreme Court visit MORE (D-Colo.), Orrin HatchOrrin HatchPETA’s call for bacon defense sparks response from Hatch Medicaid becomes big threat to GOP’s healthcare revival Unresolved issues, very little time for Senate GOP MORE (R-Utah), Tom HarkinTom HarkinDistance education: Tumultuous today and yesterday Grassley challenger no stranger to defying odds Clinton ally stands between Sanders and chairmanship dream MORE (D-Iowa), Lamar AlexanderLamar AlexanderOvernight Regulation: Trump pick would swing labor board to GOP | House panel advances bill to slow ozone regs | Funding bill puts restrictions on financial regulators Overnight Tech: Trump targets Amazon | DHS opts for tougher screening instead of laptop ban | Dem wants FBI to probe net neutrality comments | Google fine shocks tech The Prescription Drug User Fee Act must refrain from adding Right To Try provisions MORE (R-Tenn.), Mark WarnerMark WarnerOur national parks need updates; Congress can help Overnight Cybersecurity: New questions about 'ransomware' attack | Tensions between NSA chief, Trump over Russia | Senate panel asks states to publicize election hacks Senate panel to get Comey memos: report MORE (D-Va.) and Richard BurrRichard BurrOvernight Cybersecurity: New questions about 'ransomware' attack | Tensions between NSA chief, Trump over Russia | Senate panel asks states to publicize election hacks Trump trolling of Comey — Not presidential Senate panel to get Comey memos: report MORE (R-N.C.).