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FDAnews Device Daily Bulletin
June 28, 2012 | Vol. 9 No. 127
Many Recalls Tracked to Software Failures: OSEL
Software failures accounted for a quarter of all device recalls in 2011, a new annual report from CDRH’s Office of Science and Engineering Laboratories (OSEL) reveals. In response, the FDA is developing new methods and laboratory expertise to aid review staffers in identifying potential vulnerabilities and assessing risk mitigation measures. The agency is also considering “reverse engineering certain types of malware to best identify the specific protective practices … manufacturers should be employing” FDA spokeswoman Michelle Bolek said.
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