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.

More at FDA News