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

CDRH issues final rule on appeals, excluding De Novos from 517A

On 2 July 2019 the U.S. Food and Drug Administration (FDA) issued a final rule finalizing the category of "517A decisions," previously termed "significant decisions," as well as two accompanying guidance documents related to...more

7/10/2019  /  Administrative Appeals , FDA De Novo Clearance , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Medical Devices , Rulemaking Process
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