On October 31, 2023, FDA hosted a webinar to address some of the frequently asked questions the agency has received since the September 29, 2023 release of its proposed rule on laboratory developed tests (“LDTs”). The materials from the webinar are available on FDA’s CDRH Learn webpage. Importantly, FDA announced during the webinar that the agency does not currently plan to extend the comment period for the proposed rule beyond the standard 60-day timeframe, and therefore, comments are still due on Monday December 4, 2023. In both the preamble to the proposed rule and stated during the webinar, FDA specifically requests comments on the following topics:

  • Whether enforcement discretion policies would be appropriate for in vitro diagnostic products (“IVDs”) offered as LDTs for future public health scenarios (similar to the enforcement discretion for COVID-19 and Mpox tests);
  • Whether there should be special considerations for IVDs offered as LDTs that are used by academic medical centers;
  • Whether there should be special considerations for IVDs offered as LDTs that are used by small laboratories;
  • Whether there are any unintended consequences of the proposed phaseout policy for certain patient populations, such as the Medicare population or rural populations;
  • Whether a “grandfathering” approach, or allowing certain LDTs currently on the market to remain subject to enforcement discretion and be exempt from the new proposed requirements, should be considered (and, if so, how to implement such an approach without triggering the public health concerns raised by FDA in the preamble to the proposed rule);
  • Whether there should be a longer phaseout time frame (and, if so, how to implement the longer time frame without triggering the public health concerns raised by FDA in the preamble to the proposed rule); and
  • Whether FDA should consider leveraging existing third party programs, such as the New York Clinical Laboratory Evaluation Program or the Veterans Health Administration, to assist with implementation of the phaseout process.

For additional information on the LDT proposed rule, EBG’s Insight on the release of the proposed rule is available here, and a recording of EBG’s own webinar discussing the key elements of the proposed rule is available here. If you have any questions about the proposed rule and developing comments or would like to discuss these or other FDA or CLIA matters, please contact the Epstein Becker Green attorney who regularly handles your legal matters, or one of the authors of this blog post.

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