Suzanne Levy Friedman

Hogan Lovells

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Latest Posts › Food and Drug Administration (FDA)

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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

User Fee Reauthorization Bill Includes Legislation Proposed to Improve Medical Device Regulation

Last week, the Senate Committee on Health, Education, Labor and Pensions (HELP Committee) advanced the Food and Drug Administration (FDA) Reauthorization Act of 2017 (S. 934), by a vote of 21–2. ...more

5/19/2017 / Food and Drug Administration (FDA) , Medical Devices , Over The Counter Derivatives (OTC) , Pharmaceutical Industry , Proposed Legislation , Regulatory Oversight , User Fees

FDA Clarifies “Intended Use” Regulations: Knowledge Alone ≠ Intent, But Knowledge Certainly Can Be One Element in...

In its January 9, 2017 final rule addressing when tobacco products may be regulated as drugs, devices, or combination products, the Food and Drug Administration (“FDA” or “The Agency”) amended the intended use regulations for...more

1/19/2017 / Final Rules , Food and Drug Administration (FDA) , Healthcare , Manufacturers , Medical Devices , Off-Label Use , Pharmaceutical Industry , Prescription Drugs , Regulatory Standards

On the Heels of 21st Century Cures Enactment, FDA Finalizes Medical Device Accessories Guidance

On December 30, 2016, the Food and Drug Administration (FDA or the Agency) issued a final guidance document entitled Medical Device Accessories – Describing Accessories and Classification Pathways for New Accessory Types....more

1/4/2017 / 21st Century Cures Initiative , Final Guidance , Food and Drug Administration (FDA) , Healthcare , Medical Devices , Pharmaceutical Industry

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