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Medical Devices / Regulatory Affairs

Sen. Grassley Presses FDA for Action on Cybersecurity

Nov. 20, 2018

In a letter to FDA Commissioner Scott Gottlieb, Sen. Chuck Grassley (R-Iowa) asked what the agency is doing to deal with cybersecurity issues highlighted in a recent HHS Office of Inspector General (OIG) report.

Grassley called the OIG report of particular concern due to its revelations about the lack of preparedness for a cybersecurity event directed at medical devices.  The report noted inadequate testing of the agency’s capacity to respond to potential medical device cybersecurity emergencies.

The FDA, Grassley said, disagreed with OIG’s conclusions that the lack of a formal arrangement with federal partners hurts information flow about cybersecurity, as well as its conclusion that the FDA had not properly addressed device cybersecurity at the component level.

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