Drug Safety? There (Should Be) an App for That, FDA Says

November 27, 2018

The FDA is seeking public comment on how it should regulate prescription drug software apps and says some apps might have to be regulated as a device — such as a software program that uses advanced algorithms to scan skin lesions for evidence of cancer.

“Our aim is to establish a bright line between those apps that are coupled to drugs in a way that require their review as part of the pre-market drug application and those apps that can be safely advanced to patients without pre-market review,” Commissioner Scott Gottlieb said in remarks to a Reagan-Udall Foundation meeting on real-world evidence at the agency’s campus in Silver Spring, Maryland. “[T]hese lower-risk apps can be subject to post-market surveillance and monitoring,” he added, inviting public comment on a proposed framework for regulating such apps.

The agency says it’s leaning toward a light-touch approach to digital drug apps but wants to hear from the public before making any decisions.

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