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FDA Issues Two Draft Guidance Documents Related to Investigational Device ExemptionsEdward M. Basile,Laurie A. Clarke,Beverly H. Lorell, M.D.,Jessica Ringel,Elaine H. Tseng,Lynette A. Zentgraft, November 18, 2011 On November 10, 2011, the Food and Drug Administration (FDA or the Agency) issued two draft guidance documents: Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Studies, Including Certain First in Human (FIH) Studies, and FDA Decisions for Investigational Device...
FDA Issues Draft Guidance on De Novo Classification ProcessEdward M. Basile,Joanne H. Chan,Laurie A. Clarke,Elaine H. Tseng,Lynette A. Zentgraft, October 10, 2011 On October 3, 2011, FDA issued a draft guidance entitled, “De Novo Classification Process (Evaluation of Automatic Class III Designation).” In the guidance, FDA described the submission and review of petitions under the de novo classification process in section 513(f)(2) of the Federal...
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