This post is to seek input from people who are or whose companies are discussing how to respond to the FDAs announced change to enforce the regulations around Lab Developed Tests (LDTs). Much has been written about this and the similarity to the impact of EU's IVDR policy. Last week (21Mar24), a House Committee held a hearing on the impact of the enforcement. A recording is available here: https://energycommerce.house.gov/events/health-subcommittee-hearing-evaluating-approaches-to-diagnostic-test-regulation-and-the-impact-of-the-fda-s-proposed-rule. Be aware, it is the full 3 hrs of the session.
The premeeting memo layed out the background for the House Committee hearing; nicely summarizing the proposed rule and its implementation timeline:
"The preamble of the proposed rule describes a phase out of its general enforcement discretion approach for LDTs. The proposed phaseout would occur in five stages over a four-year period following the publication of the final phaseout policy. One year after the publication of the final phaseout policy, labs would be expected to adhere to adverse event reporting, correction, and removal reporting requirements. After two years, the FDA would enforce requirements other than adverse event reporting, quality systems, and premarket review requirements. Quality system requirements would be applicable three years after the publication of the final phase-out policy, while premarket review requirements for high-risk tests would be enforced after 3.5 years, but not before October 1, 2027. Finally, after four years, but not before April 1, 2028, the agency would enforce premarket requirements for moderate and low risk tests that require premarket submissions. "
CLIA labs already have quality systems and track up/downtime of their assays. However, the new rule would add additional documentation requirements including establishing the capability to submit premarket review filings. Based on the Congressional witness list both the American Clinical Laboratory Association (ACLA) and the College of American Pathologists (CAP) are discussing the issues around the rule change. Asking the members of this Community, are you or your company involved internally or with other organizations discussing or commenting on the proposed rules and their impact, in particular on clinical drug development?
#fda #LDT #CLIA
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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