IVD Office Willing To Swap Premarket Diligence For Risk-Based “Smart Regs”
This article was originally published in The Gray Sheet
Executive Summary
CDRH's Office of In Vitro Diagnostic Devices Evaluation & Safety anticipates granting more freedom to IVD manufacturers to exchange premarket information for postmarket vigilance measures in device reviews
You may also be interested in...
CDRH Reopens Analyte-Specific Reagent Rule, Expanding IVD Oversight
FDA will begin expanding oversight of homebrew in vitro diagnostics with a notice of proposed rulemaking on analyte-specific reagents in the coming weeks
CDRH Reopens Analyte-Specific Reagent Rule, Expanding IVD Oversight
FDA will begin expanding oversight of homebrew in vitro diagnostics with a notice of proposed rulemaking on analyte-specific reagents in the coming weeks
FDA Analyte-Specific Reagent Guidance Spells Out Small Lab Fundamentals
Labeling and promotional material for Class I analyte-specific reagents may bear information clarifying that FDA does not require premarket review of the tests, according to the agency