Medical Devices (includes In Vitro Diagnostics)
FDA's proposed model would impose a new regulatory structure on a significant sector of the device ecosystem. Becoming precertified under the proposed regulatory scheme will require assessments of a company's software development processes--by FDA and by the company itself. FDA's model is based on continuous process improvement, integrating information learned about marketed software into the next iteration of such software, and having a functional quality system, among other considerations. We will discuss the current status and content of FDA's proposal and describe FDA's current thinking about software regulation so that regulatory professionals can be prepared for the new model, including understanding how the new model differs from the existing regulatory paradigm for traditional (hardware) medical devices. Once the new model becomes effective, the industry will need regulatory professionals who understand how the model applies to companies who are new to being regulated by FDA. Speakers will include a former FDA device policy official who helped craft legislation related to software as a medical device as well as the current FDA official overseeing the agency's digital health program.