U.S. FDA releases draft guidance on submission requirements for management of medical device cybersecurity
October 2018
U.S. FDA releases draft guidance on submission requirements for management of medical device cybersecurity…
Links to the draft guidance and corresponding Federal Register notice are provided below:
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM623529.pdf
https://www.federalregister.gov/documents/2018/10/18/2018-22697/content-of-premarket-submissions-for-management-of-cybersecurity-in-medical-devices-draft-guidance