The U.S 2023 Omnibus bill included a little publicised addition from the FDA. Requiring the manufacturers of medical devices to implement a cybersecurity plan, including through life support for vulnerabilities, SBoM and consumer communication on vulnerabilities. Before products can be…
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…
Jamie Foster of Hill Dickinson LLP and I wrote this article to raise the awareness of U.S and EU cybersecurity regulation, that is moving rapidly to regulate cybersecurity risk management. In this instance regulation that affects Critical National Infrastructure (CNI)…
