By Daniel X. Hammer, William Calhoun, Do-Hyun Kim, Robert James, Ilko K. Ilev and Victor Krauthamer

The Food and Drug Administration’s Center for Devices and Radiological Health (FDA/CDRH) regulates medical devices and radiological products in the US. We approve new devices that are deemed to be safe and effective and clear for sale devices which are substantially equivalent to older products. A large and growing number of medical devices include lasers and coherent optical sources that require special consideration in the approval process. Moreover, newly available sources and applications have characteristics that make determination of safety difficult. The Office of Science and Engineering Laboratories (OSEL) is the research arm of CDRH, providing basic and applied scientific expertise and consultative technical review to the FDA. OSEL has expertise in biology, physics, solid and fluid mechanics, chemistry and material science, imaging and applied mathematics, and electrical and software engineering. The Division of Physics (DP) has several active research programs that relate to device laser safety. This article summarizes a few of those projects. Continue reading →