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| FDA has issued a draft guidance medical device manufacturers should take to address cybersecurity risks. |
by Jason C. Gavejian, CIP P
Principal
Jackson Lewis P.C.
Reprinted with permission
Last week (January 22, 2016), the U.S. Food and Drug Administration (FDA) issued draft guidance outlining important steps medical device manufacturers should take to address cybersecurity risks to keep patients safe and better protect the public health. The draft guidance, which details the agency’s recommendations for monitoring, identifying, and addressing cybersecurity vulnerabilities in medical devices after they have entered the market, is part of the FDA’s ongoing efforts to ensure the safety and effectiveness of medical devices in the face of potential cyber threats.