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QUOTED. March 18, 2019. Cisco Vicenty.

Executive Summary

US FDA is approving 30-day change notices at a breakneck pace for device-makers enrolled in an agency program that measures manufacturing maturity and quality. See what FDA's Cisco Vicenty said about it here.

"The average time now is … probably 2.8 days to approval for change notices [for firms enrolled in FDA's Case for Quality Voluntary Improvement Program]. One of the more interesting things we're seeing … is that some notices are being approved even more quickly than that." –Cisco Vicenty, program manager, Office of Compliance, US FDA Center for Devices and Radiological Health

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