THIS MONTH, AT LEAST THREE CLINICAL LABORATORY DIRECTORS got letters from the Food and Drug Administration raising questions about assays for the Zika virus. The letters say the tests appear to meet the FDA’s definition of a medical device and thus are subject to premarket clearance, approval, or Emergency Use Authorization. In the letters sent […]
- Regulatory Update
FDA Steps Up Test Enforcement, Saying Tests Need Clearance
- By Joseph Burns
- > From the Volume XXIII No. 4 - March 21, 2016 Issue
