FDA, Industry Look for Gaps in Cybersecurity


The US Food and Drug Administration (FDA) on Thursday kicked off a fortuitously-timed public workshop on medical device cybersecurity, the agency’s third on the subject to date.

At the workshop, FDA officials, representatives from industry and researchers are trying to determine the current gaps in regulatory science as it relates to cybersecurity with the aim of coming up with fixes for those gaps down the road.

FDA’s previous cybersecurity workshops in October 2014 and January 2016 focused on collaborative efforts on cybersecurity, such as information sharing and vulnerability disclosure and discussing FDA’s guidance documents on pre- and postmarket cybersecurity.

“What a week to pick to have the cybersecurity workshop, certainly very topical,” said Edward Margerrison, director of the Office of Science and Engineering Laboratories at the Center for Devices and Radiological Health (CDRH), referring to the “WannaCry” ransomware that struck computer systems around the world last Friday.

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Source: RAPS