LDT vs IVD: Adapting to the New FDA Regulations - MCRA Webinar

The US FDA recently released its final rule on the regulation of Laboratory Developed Tests (LDTs). MCRA’s  IVD experts have been proactively engaged in understanding and preparing for this significant regulatory development, including analyzing the quality and clinical implications. Join us as we delve into the timeline for enforcement, the key aspects of the ruling, and how your organization can align with the new FDA requirements.

Key Highlights: 

1. Summary of the final rule, areas of enforcement discretion, and staged approach to enforcement.
2. Quality Systems requirements for LDTs.
3. Engaging with FDA via different submission types.
4. Developing data to support analytical and clinical validity.

Join MCRA experts James Mullally, Julie Martel, and Dan Goldstein as they discuss this critical US FDA rule change for Laboratory Developed Tests. 
 

LDT vs IVD: Adapting to the New FDA Regulations - MCRA Webinar