Michael Kasser

Michael Kasser

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
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