(AGENPARL) – SILVER SPRING mer 29 marzo 2023 This guidance describes FDA’s RTA policy for premarket submissions submitted for cyber devices before October 1, 2023.
Fonte/Source: http://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-refuse-accept-policy-cyber-devices-and-related-systems-under-section