GAO: FDA Must Strengthen Review of Some Medical Devices
During a 2001 and 2006 premarket review of two medical devices (an implantable cardioverter defibrillator and an insulin pump) that have known vulnerabilities, the FDA considered information security risks from unintentional threats in four areas: software testing, verification and validation; risk assessments; access control; and contingency planning.
However, GAO found the FDA did not consider information security risks from intentional threats for these areas, nor did the FDA review risks of either unintentional or intentional threats for the remaining four information security control areas: risk management, patch and vulnerability management, technical audit and accountability and security-incident-response activities.
GAO has recommended the FDA implement a plan that includes at least four actions:
1. Increase its focus on manufacturers' identification of potential unintentional and intentional threats, vulnerabilities, the resulting information security risks and strategies to mitigate these risks during its postmarket review process.
2. Utilize available resources, including those from other entities.
3. Leverage postmarket efforts to identify and investigate information security problems.
4. Establish specific milestones for completing this review and implementing these changes.
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