John Smith, M.D.

John Smith, M.D.

Hogan Lovells

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FDA Finalizes De Novo Evaluation Guidance and Issues Associated Refuse to Accept Checklist

On October 30, 2017, the Food and Drug Administration (FDA or the Agency) released its final De Novo request guidance document entitled, De Novo Classification Process (Evaluation of Automatic Class III Designation) (Final...more

11/17/2017  /  De Novo Standard of Review , Final Guidance , Food and Drug Administration (FDA) , Medical Device User Fee Program (MDUFA IV) , Medical Devices , User Fees

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
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