(AGENPARL) - Roma, 13 Giugno 2023(AGENPARL) – SILVER SPRING mar 13 giugno 2023 The guidance describes FDA’s thinking on recommended documentation included in premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions.
Fonte/Source: http://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-device-software-functions