Susan Tiedy-Stevenson

Hogan Lovells

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Latest Posts › 21st Century Cures Act

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Clarifying Clinical Decision Support: FDA Overhauls Guidance To Focus On Risk

On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance entitled "Clinical Decision Support Software" (CDS guidance), which updates the framework for FDA's oversight of CDS...more

10/3/2019 / 21st Century Cures Act , Clinical Evaluations , Draft Guidance , Food and Drug Administration (FDA) , Medical Software , Mobile Health Apps , Mobile Medical Applications , Pharmaceutical Industry

Final guidance provides additional clarity to the Humanitarian Device Exemption program

On 6 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Humanitarian Device Exemption (HDE) Program." ...more

9/11/2019 / 21st Century Cures Act , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Premarket Approval Applications , Risk Assessment

Clarifying Digital Health and Software Regulation: FDA Releases Three New Guidance Documents

On December 7, 2017, the Food and Drug Administration (FDA or the Agency) released three guidance documents that together aim to clarify the framework for the regulation of software and digital health products to bring FDA...more

12/15/2017 / 21st Century Cures Act , Digital Health , Food and Drug Administration (FDA) , New Guidance , Software

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