Medical Device Network March 31, 2023
As the US government makes cybersecurity a requirement in medical devices, the FDA has issued policy guidance to vendors.
New laws passed by the US government which came into effect on 29 March 2023 gives U.S. Food and Drug Administration (FDA) authorisation to require cybersecurity adjustments in submitted medical devices. The requirement will take effect 90 days from the law being passed, giving vendors until October 1, 2023, to prepare submissions meeting the new standards.
In its newly issued guidance for cyber devices, the FDA have said they intend not to issue ‘refuse to accept’ (RTA) decisions for cybersecurity shortcomings to vendors who submitted before this deadline. The agency plans to work collaboratively with sponsors as part of the review...
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