New Paper Argues 510(k) Program Has Strengths That Critics Have Overlooked

On May 4, 2013, Hyman, Phelps & McNamara, P.C. Director Jeffrey K. Shapiro presented a draft paper and slides on the 510(k) medical device substantial equivalence program during a conference on FDA in the 21st Century.  The conference was held at the Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics (see our previous post here).  The draft paper argues that the 510(k) program is an excellent approach to the premarket review of medium risk medical devices, and has strengths that critics have overlooked.

The draft paper can be found here.  The slides presented on May 4 are available here.