Special Advocacy Update

November 20, 2023

In this Issue:

CAP Urges Members to Comment on LDT Proposed Rule before December 4 Deadline

The CAP is encouraging its members to register their written comments to the US Food and Drug Administration (FDA) regarding the proposed rulemaking on laboratory-developed tests (LDTs) before the comment period ends on December 4.

The proposed regulation would phase out the current enforcement discretion approach by the FDA for LDT oversight. The FDA would classify in vitro diagnostics (IVDs) offered as LDTs as Class I, II, or III medical devices depending on risk, and would extend FDA oversight first to higher-risk (Class III) devices then to moderate-risk (Class II), then to lower-risk devices (Class I) over the course of five years. This would be done by instituting the same general requirements as with Medical Devices: premarket review (as applicable), Quality Systems (QS), and registration and listing requirements for these tests, in addition to medical device reporting (MDR) requirements (i.e., reporting of adverse events), correction and removal reporting requirements, and others. The proposed rule is looking to institute those same requirements but somewhat tailor them to the specifics of Laboratory Developed IVDs. Once fully implemented in 2028, all IVDs offered as LDTs by a laboratory would generally fall under the same enforcement approach as other IVDs.

While the CAP and other laboratory groups have lobbied for a 60-day extension of the comment period, the FDA has stated it will not extend the comment period. Therefore, CAP members should not assume that the comment period will be extended.

If you haven’t read the proposed rule, you can find it here on the Federal Register. The FDA reviewed the details of its proposed regulation of LDTs during a webinar on October 31. You can also review the materials from the FDA’s presentation here:

The CAP encourages members to provide substantive comments on the specific impact of the proposed rule on patient access to testing and the costs and regulatory burden associated with complying with the rule. The FDA seeks specific comments and data on:

  • Should the FDA exempt tests offered prior to the rule’s enactment?
  • Is there a public health rationale to have a longer phaseout period for IVDs offered as LDTs by small laboratories with annual receipts below a certain threshold (eg, $150,000)?
  • What unintended consequences may result from the proposed phaseout policy to certain patient populations (eg, Medicare patients, rural populations, etc)?
  • Should the FDA apply general controls (the lowest risk category) on LDTs developed in academic medical centers? Other settings?
  • Should the FDA apply enforcement discretion policies for IVDs offered as LDTs for other public health scenarios beyond immediate response to emerging outbreaks?
  • Should there be enforcement discretion for clinical laboratories using New York State Department of Health Clinical Laboratory Evaluation Program or those within the Veterans Health Administration?
  • Costs of the proposed rule on laboratories complying to LDT oversight requirements. The cost estimates can be accessed here.

Submit your comments here before December 4 at 11:59 PM EST. The CAP continues to analyze the proposed rule and will be submitting its own comments by the December 4 deadline.