FDA Pilot Project Aims at Quick Approvals for Medical Software

The step is one of several efficiency initiatives outlined by Commissioner Scott Gottlieb

WASHINGTON -- The Food and Drug Administration is starting a pilot project with software and medical companies such as Apple Inc., Fitbit Inc. and Johnson & Johnson to help create swifter ways to approve new medical software.

“This is an effort to come up with a regulatory approach that is adapted to a fast-moving field,” said FDA Commissioner Scott Gottlieb in an interview. In the new framework, he said, “We will regulate firms...

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