FDA Gives Feedback to Congress on New Diagnostics Standards

FDA Commissioner Scott Gottlieb said the agency has advised Congress to take a three-pronged approach to modernizing diagnostics standards.

The agency has proposed a regulatory framework based on a few key principles, Gottlieb said in remarks at the Friends of Cancer Research’s 7th Annual Blueprint for Breakthrough Forum in Washington, D.C.

Gottlieb said regulatory agencies and policymakers should take a consistent approach for all in vitro clinical tests regardless of whether they are developed by a traditional manufacturer or a clinical laboratory.