Major Issues in Device Regulation
Moderator: W. Nicholson Price II (Petrie-Flom Center)
Jeffrey Shapiro (Hyman, Phelps, McNamara PC), Why the 510(k) Pathway is the Right Approach for Most Medical Devices
Kayte Spector-Bagdady/Elizabeth Pike (Presidential Commission for the Study of Bioethical Issues), Device-ive Maneuvers: FDA Regulation of the Bifurcation of Direct-to-Consumer Genomic Data and Information
Thomas R. McLean (American Medical Litigation Support Services)/Alexander McLean (University of Texas at Austin School of Law), Post-Market Surveillance of Medical Devices
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