Sen. Grassley Presses FDA for Action on Cybersecurity

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

Grassley was concerned by the reported lack of preparedness for a cybersecurity event directed at medical devices. The report noted inadequate testing of the agency’s capacity to respond to such emergencies.

FDA disagreed with the 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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