Suzanne Levy Friedman

Hogan Lovells

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Latest Posts › Medical Software

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FDA promotes pre-approval for changes to AI devices via Predetermined Change Control Plans

On March 30, the U.S. Food and Drug Administration (FDA) published draft guidance that proposes recommendations on the types of information that should be included in a Predetermined Change Control Plan (PCCP) in a marketing...more

4/13/2023 / Artificial Intelligence , Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Machine Learning , Medical Devices , Medical Software

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On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance entitled "Clinical Decision Support Software" (CDS guidance), which updates the framework for FDA's oversight of CDS...more

10/3/2019 / 21st Century Cures Act , Clinical Evaluations , Draft Guidance , Food and Drug Administration (FDA) , Medical Software , Mobile Health Apps , Mobile Medical Applications , Pharmaceutical Industry

FDA Issues Long-Awaited Final Guidance on When a Device Modification Requires a New 510(k)

Six years after its first attempt to update its now 20-year-old guidelines for when modifications to a 510(k)-cleared device require the submission of a new 510(k) notice, the U.S. Food and Drug Administration (FDA or the...more

11/3/2017 / Device Classification , Final Guidance , Food and Drug Administration (FDA) , Medical Devices , Medical Software , Pharmaceutical Industry

Gottlieb Announces New Regulatory Paradigm for Digital Health Software

Recognizing both the opportunities and the potential regulatory challenges presented by such rapid development, the FDA – under the leadership of recently confirmed Commissioner Dr. Scott Gottlieb – is spearheading a new...more

6/20/2017 / 21st Century Cures Act , Digital Health , Food and Drug Administration (FDA) , Medical Devices , Medical Software , National Evaluation System for Health Technology (NEST) , Regulatory Oversight

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