OIG recommends FDA enhance medical device cybersecurity review process

The Department of Health and Human Services Office of Inspector General yesterday recommended the Food and Drug Administration take additional steps to integrate cybersecurity into its premarket review process for medical devices. Specifically, OIG recommends the agency use pre-submission meetings with manufacturers to address cybersecurity concerns, and include cybersecurity documentation and criterion on the checklists and template used to guide reviews and screen them for completeness. In comments in the report, the agency agreed with the recommendations. AHA has encouraged FDA to improve medical device security.