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BRIEF-U.S. FDA Provides New Guidance To Advance Digital Health Policies​
December 7, 2017 / 4:40 PM / 7 days ago

BRIEF-U.S. FDA Provides New Guidance To Advance Digital Health Policies​

Dec 7 (Reuters) - U.S. FDA Commissioner Scott Gottlieb:

* U.S. FDA COMMISSIONER SCOTT GOTTLIEB SAYS ANNOUNCING THREE NEW GUIDANCES THAT ADDRESS, IN PART, PROVISIONS OF THE 21ST CENTURY CURES ACT

* FDA‘S GOTTLIEB SAYS THE FIRST DRAFT GUIDANCE “CLINICAL AND PATIENT DECISION SUPPORT SOFTWARE” OUTLINES FDA‘S APPROACH TO CLINICAL DECISION SUPPORT SOFTWARE

* FDA‘S GOTTLIEB SAYS THE FIRST DRAFT GUIDANCE IS INTENDED TO MAKE CLEAR WHAT TYPES OF CDS WOULD NO LONGER BE DEFINED AS A MEDICAL DEVICE

* FDA‘S GOTTLIEB - SECOND DRAFT GUIDANCE ISSUED IS “CHANGES TO EXISTING MEDICAL SOFTWARE POLICIES RESULTING FROM SECTION 3060 OF THE 21ST CENTURY CURES ACT”

* FDA‘S GOTTLIEB SAYS SECOND DRAFT GUIDANCE SPECIFICALLY OUTLINES FDA’S INTERPRETATION OF TYPES OF SOFTWARE THAT ARE NO LONGER CONSIDERED MEDICAL DEVICES

* FDA‘S GOTTLIEB SAYS FINAL GUIDANCE BEING ISSUED IS “SOFTWARE AS A MEDICAL DEVICE: CLINICAL EVALUATION”

* FDA‘S GOTTLIEB-FINAL GUIDANCE ESTABLISHES PRINCIPLES FOR REGULATORS TO USE IN EVALUATING SAFETY, EFFECTIVENESS, PERFORMANCE OF SOFTWARE AS A MEDICAL DEVICE Source text for Eikon:

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