ACLA Challenges FDA LDT Final Rule

On Wednesday, May 29, the American Clinical Laboratory Association (ACLA) filed a lawsuit challenging FDA’s final rule to regulate professional laboratory testing services. Here is a link to ACLA’s press release and to the lawsuit.

Since the announcement of the final rule there has been steady speculation that a lawsuit would be brought against the FDA. Hear more about the industry’s reaction to the rule in this UBS Webcast with XiFin CEO Lale White and COO Kyle Fetter.

Source: https://www.acla.com/acla-challenges-fdas-final-rule-to-regulate-laboratory-developed-testing-services-as-medical-devices/