Edward M. Basile

FDA Issues Two Draft Guidance Documents Related to Investigational Device Exemptions
Edward 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On November 10, 2011, the Food and Drug Administration (FDA or the Agency) issued two draft guidance documents: Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Studies, Including Certain First in Human (FIH) Studies, and FDA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FDA Issues Draft Guidance on De Novo Classification Process
Edward 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On October 3, 2011, FDA issued a draft guidance entitled, “De Novo Classification Process (Evaluation of Automatic Class III Designation).”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...

FDA Issues Draft Guidance Regarding the Design of Pivotal Clinical Investigations of Medical Devices
Edward M. Basile,Laurie A. Clarke,Beverly H. Lorell,Elaine H. Tseng,Lynette A. Zentgraft, August 23, 2011
The Food and Drug Administration (FDA) issued a draft guidance on August 15 that sets forth the agency’s recommendations regarding the design of pivotal clinical investigations of medical devices. These recommendations are intended to help manufacturers and researchers design clinical...