The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is announces its 2020 annual conference: “Innovation and Protection: The Future of Medical Device Regulation.” The conference will be held on Friday, May 8, 2020.
This year’s conference is organized in collaboration with Timo Minssen, University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law (CeBIL); Nicholson Price, University of Michigan School of Law; and Christopher Robertson, James E. Rogers College of Law of the University of Arizona.
Medical devices have historically been less regulated than their drug and biologic counterparts. In the United States, the legislative framework regulating oversight of medical devices allows a moderate-risk device to be brought to market without evidence of safety or efficacy provided it is substantially equivalent to devices that were on the market in 1976—which themselves may have never been evaluated for safety or efficacy (often referred to ask the 510(k) pathway). Post-market surveillance is also less onerous than its pharmaceutical counterpart, with an “alternative summary reporting” program allowing manufacturers to avoid public reports of certain types of problems prior to this year.
If you are interested in participating, please send a 1-page abstract of the paper you would plan to present to petrie-flom@law.harvard.edu as soon as possible, but not later than October 14, 2019.
More information, including the full call is available here.
