Multiplex Testing: FDA Solicits Guidance, Device Submissions From Industry
This article was originally published in The Gray Sheet
Executive Summary
CDRH is considering drafting a separate guidance for multiplex tests and microarrays that would focus on issues related to quality system regulations and good manufacturing practices
You may also be interested in...
FDA Genetic Array Submissions Guidance Dovetails With NCCLS Effort
FDA's guidance on "Pharmacogenetic Tests and Genetic Tests for Heritable Markers," to be issued by year-end, will exclude gene expression arrays, according to the agency
FDA Genetic Array Submissions Guidance Dovetails With NCCLS Effort
FDA's guidance on "Pharmacogenetic Tests and Genetic Tests for Heritable Markers," to be issued by year-end, will exclude gene expression arrays, according to the agency
Multiplex Testing: CDRH Guidance Provokes Array Of Industry Comments
Abbott Labs is urging CDRH to clarify that its April 1draft guidance on multiplex tests for heritable markers, mutations and expression patterns applies only to device submissions