FDA Updates Templates for Serology Test EUA Requests
The updates clarify FDA’s previous recommendations for demonstrating clinical performance and presenting validation data and provide new recommendations.
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Clinical Chemistry Reference Kit
The set of definitive method reference materials contains seven routine chemistry components, covering 42 individual concentrations.
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Managing Prior Authorizations with Artificial Intelligence
AI-driven software can help labs expertly navigate the prior authorization landscape.
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FDA Proposes to Reclassify Two Types of Hepatitis C Virus Diagnostic Tests
If the agency’s proposed reclassification is finalized, devices of this type may go through the 510(k) pathway for clearance instead of the premarket approval (PMA) pathway.
Read MoreDigital Pathology Association Commends CMS for Waiving Restrictions on Remote Pathology Diagnoses
The waiver will provide temporary relief from federal regulations requiring pathologists to render primary diagnoses onsite at healthcare facilities.
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