A Lifelong Commitment: FDA Releases Postmarket Guidance on Cybersecurity Risk Management for Medical Device Manufacturers

On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance titled “Postmarket Management of Cybersecurity in Medical Devices,” setting forth proposed recommendations for the medical device industry as well as FDA staff on the management of cybersecurity vulnerabilities in networked medical devices (such as insulin pumps, pacemakers and defibrillators) already in the marketplace.

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