Knowledge Is Not Enough For Enforcement In FDA’s Final Research-Use Dx Guidance
This article was originally published in The Gray Sheet
Executive Summary
Companies are at risk of enforcement if they take direct steps to encourage use of their research-use or investigational-use only tests for clinical diagnostic indications, according to the guidance. But, in response to public comments, FDA removed references that a company knowing or having “reason to know” that a lab is inappropriately using a test is grounds for enforcement.
You may also be interested in...
What's Next For LDTs? FDA May Be Eyeing A New Game Plan
Following the agency's signal to stakeholders that it will not be finalizing a regulatory framework for laboratory-developed tests this year, industry experts suggest some other approaches FDA could take to address lab tests of all stripes.
FDA Comes Down Hard On 23andMe, Putting Consumer-Directed Genetic Testing On Notice
The agency tells direct-to-consumer genetic testing company 23andMe in a strongly-worded warning letter that it should immediately stop marketing its Personal Genome Service until it can gain clearance. The firm says it will address the agency’s concerns.
Lab-Developed Test Regs In Spotlight With Citizen Petition, Hamburg Speech
The American Clinical Laboratory Association filed a citizen petition with FDA June 4 reiterating and formalizing its long-held opposition to FDA regulating laboratory-developed test services. The petition closely followed a speech from FDA Commissioner Hamburg emphasizing plans to do just that.