Today, on April 29, 2024, following more than a decade of discourse, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released its long-awaited “Medical Devices; Laboratory Developed Tests” Final Rule (the “Final Rule”) formalizing the Agency’s authority to regulate laboratory developed tests (“LDTs”) as medical devices.

Since FDA issued its Proposed Rule (the “Proposed Rule”) in the Fall of 2023, Epstein Becker Green (EBG) and other industry stakeholders have eagerly awaited FDA’s issuance of the Final Rule and have speculated as to the provisions the Agency would choose to finalize.

Now, with the wait finally over, EBG joins the rest of industry in our review of the Final Rule, and we will be preparing a more in-depth analysis of the Final Rule and its potential impact on laboratories and the nationwide healthcare system. For now, here are important preliminary takeaways from the Final Rule.

Key Takeaways

FDA’s Plans to Exercise Enforcement Discretion for Certain Existing LDT Categories

The change most likely to jump off the Federal Register page for labs currently offering LDTs on the market is the inclusion of several declarations made by FDA that the Agency intends to exercise different levels of enforcement discretion for certain categories of existing LDTs, as summarized below:

• FDA does not intend to enforce the requirements for any LDTs manufactured and performed within the Veterans Health Administration (“VHA”) or the Department of Defense (“DoD”)
• FDA generally does not intend to enforce premarket review requirements for LDTs approved by the New York State Clinical Laboratory Evaluation Program (“CLEP”)
• FDA generally does not intend to enforce premarket review requirements and quality systems requirements (except for records requirements under Part 820, subpart M) for:
  • LDTs manufactured and performed by a lab integrated within a healthcare system to meet an unmet need of patients receiving care within the same healthcare system;
  • In vitro diagnostics (“IVD(s)”) offered as LDTs first marketed prior to the date of issuance of the Final Rule and that are not later modified, or are only modified in certain limited ways as specified in the Final Rule; and
  • Non-molecular antisera LDTs for rare red blood cell antigens manufactured and performed in blood establishments, including transfusion services and immunohematology labs, when no alternative available would meet the patient’s need for a compatible blood transfusion.

Although the Final Rule addresses a number of commenter concerns through the addition of the grandfathering clause, permitting the leveraging of CLEP approval, and allowing continued access to LDTs where alternatives do not exist and to address unmet needs in healthcare systems, subject to phase-out provisions, various postmarket requirements apply even to these categories of LDTs. For example, NYS CLEP-approved LDTs that are exempt from FDA premarket requirements are still subject to quality system requirements. Grandfathered tests, as well as LDTs manufactured by labs integrated with healthcare systems for unmet needs, are exempt from premarket review and most quality system requirements, but they will still be subject to recordkeeping requirements including complaint handling consistent with FDA standards. Medical Device Reports (“MDRs”) from serious injuries and malfunctions (e.g., erroneous results that do or could result in misdiagnosis of a serious medical condition) will also generally apply, as will registration (and associated annual fees) and device listing in most cases in accordance with the phase-out.

FDA’s Four-Year Phase-Out Structure

In addition to the enforcement discretion categories, FDA finalized the four-year phase-out structure:

• Stage 1: Beginning one year after the publication date of the Final Rule, FDA will expect compliance with MDR requirements, correction and removal reporting requirements, and quality systems requirements under § 820.198 (21 C.F.R. § 820.198) (complaint files);
• Stage 2: Beginning two years after the publication date of the Final Rule, FDA will expect compliance with requirements not covered during other stages of the phase-out policy, including registration and listing requirements, labeling requirements, and investigational use requirements;
• Stage 3: Beginning three years after the publication date of the Final Rule, FDA will expect compliance with quality systems requirements under Part 820 (21 C.F.R. Part 820) (other than requirements under § 820.198 (complaint files), which are already addressed in Stage 1);
• Stage 4: Beginning three and a half years after the publication date of the Final Rule, FDA will expect compliance with premarket review requirements for high-risk IVDs offered as LDTs (IVDs that may be classified into class III or that are subject to licensure under section 351 of the Public Health Service Act), unless FDA has already received a premarket submission by the beginning of this stage—in which case, FDA intends to continue to exercise enforcement discretion for the pendency of its review; and
• Stage 5: Beginning four years after the publication date of the Final Rule, FDA will expect compliance with premarket review requirements for moderate-risk and low-risk IVDs offered as LDTs (that require premarket submissions), unless FDA received a premarket submission by the beginning of this stage—in which case, FDA intends to continue to exercise enforcement discretion for the pendency of its review.

Unlikely to be Rolled Back Under the Congressional Review Act

Notably, FDA issued the Final Rule before May, which means the Final Rule would likely escape being designated a “midnight rule” subject to rollback under the Congressional Review Act if the upcoming presidential election results in a different administration. However, stakeholders should be on the lookout for other legal challenges to the Final Rule. EBG certainly will.

Live Webinar on the LDT Final Rule: May 14, 2024

FDA also announced its plans to host a live webinar on the Final Rule on May 14, 2024. The Agency states that in the one-hour webinar, FDA will provide an overview of the Final Rule and will describe the phase-out of FDA’s general enforcement discretion approach to LDTs.

FDA will not accept questions during the webinar but requests that stakeholders submit any questions for public discussion to CDRHWebinars@fda.hhs.gov by May 7, 2024. Registration is not necessary, but FDA advises participants to dial in 15 minutes prior to the 1 p.m. start time. FDA plans to make the presentation, slides, and transcript available at CDRH Learn under “In Vitro Diagnostics” after the webinar and requests that stakeholders email questions about the Final Rule to LDTFinalRule@fda.hhs.gov.

Epstein Becker Green Staff Attorney Ann W. Parks contributed to the preparation of this post.