FDA and CMS Repeat a 2015 Message: That FDA Must Regulate LDTs, and CLIA Can't Handle "Validity"

On January 18, 2024, CMS and FDA issued a joint communication to Americans, headlining that FDA must regulate LDTs, and that CLIA cannot handle topics like clinical validity and utility of LDTs.

Find it here:

https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-and-cms-americans-deserve-accurate-and-reliable-diagnostic-tests-wherever-they-are-made?utm_medium=email&utm_source=govdelivery

Or here:

https://www.cms.gov/newsroom/press-releases/fda-and-cms-statement-americans-deserve-accurate-and-reliable-diagnostic-tests-wherever-they-are

FDA writes that, "The current approach has enabled some tests to enter the market with unfounded claims of innovation."

The phrasing, "The message is attributed to Jeff Shuren" seems quirky to me. 

See a law firm article by Gonzales & Mullens here. 

Deja Vu

This is exactly the same messaging as was presented to Congress in 2015 and by the same parties - being Jeff Shuren MD, FDA, head of devices, and the Chief Medical Officer of CMS, in this case, being Dora Hughes MD [Acting].  (The new 2024 press release actually does mention the 2015 hearing).

Here's my 2015 blog on the LDT hearing:

https://www.discoveriesinhealthpolicy.com/2015/11/house-posts-video-of-fda-ldt-hearing-on.html

Even earlier - the 2015 hearing stuck close to CMS's 2013 fact sheet.

https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/ldt-and-clia_faqs.pdf

AI Corner

Here's an AI summary of the new 2024 document.

The FDA and CMS emphasize the critical need for accurate and reliable diagnostic tests, addressing the evolving landscape of laboratory developed tests (LDTs). Here are three key takeaways:

• Critical Role of Laboratory Tests: Laboratory tests are integral to healthcare decisions, with about 70% of such decisions relying on these tests. The accuracy of these tests is vital, especially for critical illnesses like cancer, where an incorrect test result can have life-altering consequences.
• FDA and CMS Oversight and Proposed Changes: Historically, the FDA had a hands-off approach to LDTs due to their simplicity and local utility. However, with the increasing complexity and risks associated with modern LDTs, the FDA proposes new regulations to ensure their safety and effectiveness, bringing them under similar oversight as other diagnostic tests. CMS, through CLIA, plays a complementary role in ensuring test accuracy but lacks the expertise to assure test functionality, which is the FDA's domain.
• Importance of Reliable Testing and Regulatory Adaptation: The recent pandemic highlighted the need for reliable testing. The FDA and CMS aim to adapt their regulatory approaches to ensure the clinical accuracy of all tests, including LDTs. This adaptation seeks to protect patients from risks associated with inaccurate tests and encourages responsible, science-based innovation in test development.