John Smith, M.D.

John Smith, M.D.

Hogan Lovells

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De Novo requests: FDA releases updated RTA checklist

On 9 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Acceptance Review for De Novo Classification Requests." ...more

9/10/2019  /  De Novo Standard of Review , FDA De Novo Clearance , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry

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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