FDA lays out device cybersecurity requirements

Manufacturers of medical devices must now show regulators when they apply to the FDA for authorization that they can monitor and address cybersecurity threats once products are on the market.

FDA lays out device cybersecurity requirements – POLITICO

Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FDC Act (fda.gov)

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