Key Things Labs Need to Know about the FDA’s Final LDTs Rule

In September 2023, the FDA released its proposed rule for regulation of lab-developed tests (LDTs), resulting in many concerns from the lab industry. Stakeholders in the lab industry have long opposed FDA oversight of LDTs, saying the added costs and regulatory hurdles would limit both innovation and patient access to critical tests, among other key issues. The FDA has now released its final version of the rule. This webinar will discuss what lab leaders need to know most about the rule, and steps they can take to prepare.