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.
Lab Group Urges FDA To Wait For Congress On LDT Issue
Jeff Shuren recently spoke at the annual American Clinical Laboratory Association industry meeting where the device center director was grilled on FDA's plans to regulate lab-developed tests. While ACLA President Alan Mertz appreciates Shuren's willingness to engage, his group continues to push back hard against the agency's plan to move forward with a final LDT plan before Congress has a chance to act.