The commercial clinical lab industry says FDA should hold off from finalizing a guidance to actively regulate laboratory developed tests until Congress has had the chance to introduce legislation on the topic.
Alan Mertz, president of the American Clinical Laboratory Association, says while he appreciates that Center for Devices and Radiological Health Director Jeff Shuren spoke directly to ACLA member companies during...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?