United States of America: Cybersecurity requirements for medical devices
Progress
Current status
adopted
29 Mar 2023 adopted
Scope
Implementers
United States of America
Policy Area
Data governance
Policy Instrument
Cybersecurity regulation
Regulated Economic Activity
technological consumer goods
Government Branch
executive
Government Body
other regulatory body
Implementation Level
national
Timeline of events
Adopted FDA Guidance on Cybersecurity Standards in Medical Devices
On 29 March 2023, the Food and Drug Administration (FDA) issued a guidance to clarify provisions of Section 524b of the Federal Food, Drug, and Cosmetic Act (FDCA). Companies manufacturing cyber devices should meet specific cybersecurity requirement…
Event type
outline
Action type
adoption
Government branch
executive
Government body
other regulatory body