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FDA issues draft cybersecurity recommendations

Biomedical // The Food and Drug Administration (FDA) recently issued draft guidance for medical device manufacturers on monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices after they enter the market. “All medical devices that use software and are connected to hospital and health care organizations’ networks have vulnerabilities — some we can proactively protect against, while others require vigilant monitoring and timely remediation,” says Suzanne Schwartz, M.D., acting director of emergency preparedness/operations and medical countermeasures in the FDA’s Center for Devices and Radiological Health. The agency is accepting comments on the draft guidance.

CLICK HERE to download the draft FDA guidance document, UCM482022.pdf.