US FDA Updates Guidance on Premarket Review Appeals and Deficiency Letters
October 2, 2017
By Neozene

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has updated guidance documents covering appeals processes and procedures for medical device premarket review decisions, as well as for developing requests for additional information for FDA registrants whose applications are deemed deficient. First, CDRH has updated guidance on its appeals process for premarket reviews as mandated by the 21st Century Cures Act of 2016. The update covers three key questions: What is a “significant decision?” What is a “substantive summary?” Who may request documentation regarding CDRH premarket review

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