Regulatory Science Relevant to Products Containing Nanotechnology

Date: 04/02/2014
Time: 4:30 pm – 5:30 pm
Location: 111 Snell Library
Speaker: Subhas G. Malghan, PhD, Deputy Director, Devices and Radiological Health, FDA

The incorporation of nanotechnology in medical devices is progressing in accordance with the classical technology development cycle where simple to manufacture products are coming to market first, and more complex products are expected in the future as manufacturing expertise and science base mature. The Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration, has the responsibility for regulatory review of medical devices and radiological products, including in-vitro diagnostic products. CDRH scientists continue to examine the broad field of nanotechnology relevant to the medical device landscape and have developed a few measures to address science as well as regulatory needs of the Center. These include building knowledge base, experimental expertise, collaborative research as well as standards coordination. This talk will address a brief overview of FDA Centers, challenges in regulatory science in reviewing products containing nanoscale materials, and my experience in FDA as a regulatory scientist.

Dr. Subhas Malghan is with the Food and Drug Administration where he is the Deputy Director in the Office of Science and Engineering Laboratories, the laboratory arm of the Center for Devices and Radiological Health. At CDRH/FDA, he is responsible for managing and directing a program on prioritization of laboratory science, the goal of which is to conduct high priority laboratory research to meet regulatory needs of the Center. In addition, he coordinates nanotechnology research in the Center as well as serves as a member of the newly organized FDA nanotechnology taskforce.