ALERT: Recent guidance from the Food and Drug Administration (“FDA”) clarifies a procedural issue for premarket submissions related to cybersecurity of medical devices and emphasizes.
On March 29, 2023, and March 30, 2023, the U.S. Food & Drug Administration (“FDA”) issued a series of FAQs and a guidance document clarifying the agency’s intended implementation of the.
Guidance documents from FDA clarifying agency implementation of Consolidated Appropriations Act that amended Section 524B of the Food Drug and Cosmetics Act to require the demonstration of cybersecurity safeguards in pre market submissions for certain medical devices.
Medical device manufacturers form part of the first line of defense that health delivery organizations (HDOs) rely upon to manage and combat a cybersecurity attack.