A formal methods approach to medical device review

Agencies such as the US Food and Drug Administration need effective means for assuring that medical software is safe and reliable. The FDA has been striving for a more rigorous engineering-based review strategy to provide this assurance. Although regulatory processes work reasonably well for device production processes, they're insufficient for assessing software. To address this problem, researchers at the FDA's Center for Devices and Radiological Health/Office of Science and Engineering Laboratories (CDRH/OSEL) have been collaborating with university researchers to explore ways to use formal modeling methods and static analysis techniques to improve the review process. These techniques include developing usage models to aid premarket review and using abstraction-driven slicing techniques to facilitate postmarket forensic analysis.