From Discretion to Regulation: What FDA's Final Rule Means for Laboratory Developed Tests

In April 2024, the Food and Drug Administration (“FDA”) issued a Final Rule amending the definition of in vitro diagnostics products (“IVDs”) found in 21 C.F.R. § 809.3. The Final Rule completely changed the regulatory status of Laboratory Developed Tests (“LDTs”) by adding the following additional language: “including when the manufacturer of these products is a laboratory.” With this seemingly simple change, the FDA has asserted jurisdiction over LDTs, making them subject to the FDA’s oversight under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”), implementing regulations and ending the FDA’s general enforcement discretion approach for LDTs. The Final Rule is set to take effect on July 5, 2024.

The Final Rule, at over 150 pages in length, expands upon the previously issued Proposed Rule dated October 3, 2023 (see our prior client alert here), which aimed to bring LDTs under similar regulatory scrutiny as other IVDs. It establishes the FDA’s final policy to progressively phase out its general enforcement discretion approach for most LDTs over the course of four years, and the FDA’s position on certain categories of LDTs that have never been the subject of enforcement discretion, such as direct-to-consumer tests.

As a result of the Final Rule, LDT manufacturers will now be required to comply with a wide array of medical device regulatory requirements (with limited exceptions) including premarket review, quality system regulations and adverse event reporting. Additional details are outlined below.

Highlights from the Final Rule

The Final Rule establishes a structured five-stage phaseout for ending enforcement discretion for LDTs, intended to ensure a smooth transition to full FDA regulation. This phaseout is scheduled to occur over four years, starting from the publication date of the Final Rule on May 6, 2024.

Stage 1: Effective May 6, 2025

One year after the Final Rule’s publication, the FDA will enforce medical device reporting requirements, including adverse event reporting, correction and removal reporting and maintenance of complaint files under quality system regulations (21 C.F.R. Part 820).

Stage 2: Effective May 6, 2026

Two years after the Final Rule’s publication, the FDA will expand its regulatory scope to include establishment registration and listing, labeling and investigational use requirements.

Stage 3: Effective May 6, 2027

Three years after the Final Rule’s publication, the FDA will enforce all remaining quality system requirements (under 21 C.F.R. Part 820), providing added oversight over the quality management of LDTs.

Stage 4: Effective November 6, 2027

Approximately three and a half years after the publication of the Final Rule, high-risk (Class III) IVDs offered as LDTs must comply with premarket review requirements. The FDA notes that it will continue to exercise enforcement discretion during the review of premarket submissions received by this stage.

Stage 5: Effective May 6, 2028

Four years following the publication of the Final Rule, the FDA will enforce premarket review requirements for moderate (Class II) and low-risk (Class I) IVDs (i.e., tests subject to de novo or 510(k) requirement) offered as LDTs. Premarket submissions must be submitted by this date, although the FDA will continue to exercise enforcement discretion while these reviews are pending.

Limited and Targeted Enforcement Discretion

The Final Rule outlines specific enforcement policies for certain categories of LDTs. These policies specify the levels of discretion the FDA intends to apply to certain categories of LDTs regarding premarket review and quality system requirements.

Category:	Description:
Full Enforcement Discretion: FDA intends to continue the general enforcement discretion approach and generally not enforce any applicable requirements for the following tests:	“1976-type” LDTs (LDTs using manual techniques—without automation—and legally marketed components) Certain Human Leukocyte Antigen Tests for Transplantation Forensic (Law Enforcement) Tests Department of Defense or Veterans Health Administration Performed Tests Public Health Surveillance Tests
Limited Enforcement Discretion: FDA generally intends to exercise enforcement discretion with respect to premarket review and/or most quality system requirements, as applicable, for:	Nonmolecular Antisera LDTs for Rare Red Blood Cell Antigens (when such tests are manufactured and performed by blood establishments) Certain Modifications by a Laboratory of Another Manufacturer’s 510(k) Cleared or De Novo Authorized Test (if the modification would not significantly affect the safety or effectiveness of the test and does not constitute a major change or modification in intended use, and where the modified test is performed only in the laboratory making the modification) LDTs approved by the New York State Department of Health Clinical Laboratory Evaluation Program (also includes conditionally approved or within an approved exemption) LDTs Marketed Prior to Issuance of Final Rule (May 6, 2024) (and not modified after that date, or modified only in certain limited ways not beyond the scope described in the preamble) LDTs for Unmet Needs by Labs Integrated in the Health Care System Treating the Patient
No Enforcement Discretion: The Final Rule restates the FDA’s long-standing position that certain categories of tests have never been subject to its enforcement discretion. The FDA expects the following tests will continue to comply with applicable device requirements under the FD&C Act:	IVDs Offered as LDTs within Scope of Phaseout Policy (but that do not fall within a targeted enforcement discretion policy) Direct-to-Consumer Tests (without meaningful involvement by a licensed health care professional) Screening Tests for Blood Donors, as well as donors of human cells, tissues and cellular and tissue-based products (HCT/Ps) Tests Intended for Emergency Use per Section 564 of the FD&C Act Collection Devices

For a high-level overview of other key categories of IVDs covered in the preamble to the Final Rule, please see FDA’s chart here, which outlines the compliance requirements for different categories of IVDs across several stages of regulatory expectations.

Practical Takeaways

Prepare for Regulatory Compliance and Increased Oversight

Stakeholders not previously regulated by the FDA, but involved in the development and use of LDTs, should prepare for increased regulatory oversight. Despite potential legal challenges, stakeholders should conduct a comprehensive review of all marketed tests and those in development and determine how each test would be regulated. Stakeholders should also start to evaluate their current policies and procedures and outline a plan for meeting the FDA’s phased-out timeline for LDT regulation.

Stay Informed and Take Initiative

The Final Rule marks a crucial shift in LDT regulation, aligning them more with the broader medical device regulations enforced by the FDA. Stakeholders should stay informed through continuous engagement with legal counsel, the FDA and those involved in the development and use of LDTs.

To learn more about the significance of the FDA’s New Rule, join Hall Render attorneys on June 11 at 1:00 PM ET for a 60-minute webinar. This session will offer an in-depth look at key provisions, exemptions, compliance deadlines and enforcement discretions, along with valuable insights into how these regulations may impact laboratory operations. This webinar, designed for legal and compliance professionals, health care practitioners involved in LDT development and those engaged in day-to-day laboratory operations, will deepen your understanding of the new requirements and their implications for current and future LDTs.

For tailored insights and guidance on how the Final Rule could impact your laboratory, please contact:

Melissa Markey at (248) 740-7505 or mmarkey@hallrender.com;
Carolina Wirth at (202) 780-2989 or cwirth@hallrender.com;
Avi Kerendian at (214) 615-2038 or akerendian@hallrender.com; or
Your primary Hall Render contact.

Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.