FDA planning to require cybersecurity checks in device submissions

While the FDA has addressed threats to networked medical devices through its guidance and product evaluations, the agency should take more steps to fully integrate cybersecurity into its premarket reviews, according to an HHS report.The HHS inspector generals office recommended (PDF) the FDA and manufacturers use presubmission meetings to better address cybersecurity-related questions, and that the agency include cybersecurity as an element in its SMART template used in 510(k) submissions.In addition, the office urged the agency to begin requiring cybersecurity documentation elements on its refuse-to-accept checklists. The FDA said it concurred with all three of HHS recommendations and has begun taking steps to implement them.

Source: https://www.fiercebiotech.com/medtech/fda-planning-to-require-cybersecurity-checks-device-submissions