FDA's Proposed Rule on LDTs and Implications for Laboratories

January 29, 2024 By: Quadax

On-demand webinar reviewing the proposed changes to 21 C.F.R. Part 809 and their potential impact on labs.

January 11th, we had the pleasure of hosting a webinar (posted below) with Christine Bump, the Principal and Founder of Penn Avenue Law and Policy. She shared a wealth of knowledge regarding the proposed amendments to 21 C.F.R. Part 809 and their potential impact on laboratories. Additionally, Christine delved into the uncertainties and challenges that laboratories may encounter, offering valuable guidance on how to navigate these forthcoming changes.

Background: On March 1, 2023, the FDA made an important announcement, indicating its intention to begin the process of notice and comment rulemaking for lab developed tests (LDTs). Moving forward to October, the FDA revealed its proposed rule, with the aim of regulating LDTs as in vitro diagnostic devices (IVDs). At the core of this proposed rule is the goal to merge LDTs with the existing definition of IVDs, eliminating the distinction between the two. This implies that all laboratory tests, regardless of their nature, would come under the jurisdiction of the FDA, necessitating their classification as class I, II, or III devices under the Federal Food Drug and Cosmetic Act and FDA's regulation. This significant shift could have far-reaching implications for the entire industry.

Webinar Highlights:

  • How Did We Get Here:
    A historical perspective on the evolution leading to the proposed rule.
  • Proposed Amendment to 21 C.F.R. Part 809:
    In-depth analysis of the key amendments proposed by the FDA.
  • Proposed Phaseout of Enforcement Discretion:
    Understanding the implications of the proposed phaseout and its timeline.
  • Impact on Industry and FDA:
    Exploring the potential impact on laboratories and how the FDA envisions its role.
  • Repercussions on Reimbursement:
    Reviewing the impact of potential new CPT codes or Z codes and the impact on reimbursement. 

Regardless of the outcome, the repercussions for laboratories will be significant. It is imperative that labs proactively start their preparations for the release of the final rule by thoroughly reviewing and making necessary arrangements to ensure compliance.

Keep an eye out for another insightful webinar featuring Christine once the FDA's rule is finalized and officially released. Join us and stay updated on the latest developments in this rapidly evolving situation!

NOTE: During the presentation, Christine highlighted the many lobbying efforts seeking to amend, modernize, and strengthen CLIA as a less burdensome means by which to address concerns about LDTs. But on January 18th, FDA and CMS released a joint statement asserting that CMS supports FDA regulation of LDTs and that expanding CLIA is not the answer. This situation is evolving rapidly, so stay tuned for more updates!


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