In a May 31, 2018, letter to Commissioner Scott Gottlieb, HIMSS offered comments to Food and Drug Administration’s (FDA) Developing a Software Precertification Program: A Working Model. In this letter, HIMSS leverages its members’ expertise to offer feedback on the FDA’s Precertification Program to help provide a more streamlined and efficient regulatory oversight of software-based medical devices from manufacturers who have demonstrated a robust culture of quality and organizational excellence (CQOE) and committed to monitoring real world performance.
HIMSS supports FDA’s drive to modernize its approach to medical device regulation and to rethink the pathway to market for software products which function as medical devices (SaMD). HIMSS encourages FDA to continue to innovate on this area in recognition of the increasing role these devices play in care provision and the modern, rapid, and iterative approaches many manufactures use in SaMD development.
HIMSS encourages the FDA to recognize and support the changing nature of healthcare delivery when considering evolving regulatory schemes. This includes a movement from diagnosis and treatment to detection and prevention and a change in the care-delivery from hospitals and clinical offices to the home and other non-traditional spaces. HIMSS believes this will require an increased focus on the use of medical devices by patients and consumers, and we ask that FDA make as much information as possible about the Precertification Program and products utilizing this new pathway publicly available in easy to understand formats.