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Device Lawyer: FDA’s Pre-Cert Update Seems Promotional, Lacks Answers

By Beth Wang / July 25, 2019 at 11:18 AM
FDA last Thursday (July 18) touted positive results from its voluntary software precertification test program and laid out next steps. But a device lawyer likens the update to promotional language not typical of regulatory agencies, and says FDA left important questions unanswered, including whether the program can be manipulated so that certain companies have an unfair advantage over other companies. The agency kicked off the program in May with the goal of confirming the pre-cert framework can provide the same...


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