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On the 30th March 2023 the U.S Food and Drug Administration (FDA) issued guidance to ‘Ensure Cybersecurity of Medical Devices’. The Refuse to Accept Policy under section 524B of the FD&C Act was effective on the 29th March 2023 and is being implemented without prior comment. It comes into force from the 1st of October 2023.
See the update written my myself and Jamie Foster of Hill Dickinson LLP here (https://lnkd.in/eCqb6CqW), were we discuss the FDA provision in more depth. Close attention should be paid to page 5 of the policy, especially opinion (b) (4). Please reach out if you are a device manufacture and require help and guidance on compliance.
From the guidance the FDA plans to work collaboratively with suppliers, but may ‘Refuse to Accept’ premarket submissions required under 524B.
Ted Dziekanowski Rachel V. Rose, JD, MBA Stephen Pitt-Walker, JD, FGIA
#cybersecurity #cyberriskmanagement #fda #cyberregulation
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