Dark Reading November 20, 2023
New cybersecurity regulations from the FDA outline specific steps that medical device companies must take in order to get their devices approved for market.
Recently, the Food and Drug Administration (FDA) issued updated regulations regarding medical devices, specifically related to the cybersecurity requirements of those devices. These new requirements are found in Section 524B, Ensuring Cybersecurity of Devices, of the Food, Drug, and Cosmetic Act (FD&C Act).
The new regulations officially went into effect on October 1, 2023, so chief information security officers (CISOs) and other security leaders working for medical device companies need to prioritize compliance to avoid having their new devices refused by the FDA, under the organization’s Refuse to Accept (RTA) policy.
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