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Device Expert Worries FDA Might Not Get Takers For Pre-Cert Test Plan

By David Roza / May 30, 2019 at 12:27 PM
A medical device regulatory expert raised concerns that companies may see no benefit from participating in FDA’s newly announced plan to test its software precertification program, and, given the added burdens of doing so, there might not be enough volunteers to properly test the program. But the expert suggested that device makers might eventually see shortened review times if the pre-cert test is successful. FDA’s goal in the test is to find out whether the pre-cert Excellence Appraisal and streamlined...


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