Researchers at the FDA’s Office of Science and Engineering Laboratories investigating new techniques for analyzing software in medical devices are using static analysis tools to uncover potential flaws in a device under review. The Center for Devices and Radiological Health (CDRH) at the FDA is responsible for post-market surveillance of medical devices. If a device failure resulting in actual or potential serious injury or death is reported, the manufacturer of the medical device is required to investigate, determine the root cause and contributory factors, develop appropriate corrective actions, and report their findings to CDRH.
