FDA proposes voluntary program for review of “software-as-a-medical-device” products. The FDA says current regulation of medical device hardware “is not well-suited for the faster, iterative design, development, and type of validation used for SaMD,” FDA says. Vendors’ “cybersecurity responsibility” is one of five areas of excellence that FDA would assess for participating in the pre-certification program. Some security experts say the FDA’s proposed plan could help promote innovation but must keep a close eye on vendors’ cybersecurity practices.”]
Source: https://www.careersinfosecurity.com/fda-unveils-plan-for-software-as-medical-device-review-a-10925