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- New Resource! The CAP’s Laboratory-Developed Test Oversight Webpage
How will you determine if a test meets Food and Drug Administration (FDA) regulatory requirements for laboratory-developed tests (LDTs)? Confused on how and when you will need to be compliant with the new rule? The CAP has combined multiple resources on one easy to follow webpage that provides the following:
- The stage/phase one requirements beginning May 6, 2025
- A place to submit questions about FDA LDT oversight
- The May 2024 CAP webinar: Preparing for Implementation of FDA’s Laboratory-Developed Test Final Rule and downloadable presentation slides
- Frequently asked questions
- Resource documents
- Links to CAP legislative action on LDT’s dating back to 2010
Check it out and “favorite” the link: Laboratory-Developed Test Oversight. The site will be updated regularly as new information and resources become available.
