HR 201, introduced by Rep. George T. Darany (D-Dearborn), references draft guidelines issued by the FDA in 2011 on app regulation, and expresses disappointment that two years later, the regulations have not been finalized.
“Thus, application developers are unable to create mobile medical applications with confidence,” the bill states. “They could be subject to indeterminate regulations at any given time, which may retroactively affect an application that has already been developed and distributed.”
Additionally, “due to the rapid growth and potential of the mobile medical application market, it is necessary that the FDA issue its final guidance as soon as possible to ensure public safety and continued development of this market. A final set of guidelines will provide certainty to all mobile medical application developers, help bring these applications to market, and allow American health consumers to access the many benefits of these applications.”
The bill has been referred to the House Committee on Health Policy.
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