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.