The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency’s general enforcement discretion approach to such devices.

On September 29, 2023, the U.S. Food and Drug Administration (“FDA”) announced a proposed rule to amend its regulations to make explicit its position that in vitro diagnostic products (“IVDs”) are devices under the Federal Food, Drug, and Cosmetic Act “including when the manufacturer is a laboratory.” The move, which proposes adding language to 21 CFR § 809.3, initiates notice-and-comment rulemaking on a matter garnering both strong opposition and support. If adopted, the rule would considerably shift FDA’s approach to laboratory developed tests (“LDTs”), with significance not only for clinical laboratories and device manufacturers, but also for patients, practitioners, and other stakeholders across U.S. health care.

In the proposed rule, FDA has asserted it has the authority to regulate LDTs as medical devices, although it has historically exercised enforcement discretion over most LDTs. In the October action, FDA signals its intent to actively regulate LDTs by ending—over a period of several years— a decades-long approach to enforcement discretion. If the proposed rule and phaseout policy are finalized as written, laboratories would be required to take up device regulatory obligations, beginning with Medical Device Report and correction and removal reporting requirements no later than one year after finalization, and culminating in meeting relevant premarket review requirements between 3½-4 years after publication.

FDA proposes the phaseout policy to apply to IVDs manufactured and offered as LDTs, regardless of whether the IVDs fit FDA’s traditional understanding of an LDT (i.e., designed, manufactured, and used within a single laboratory). However, FDA proposes not to extend the phaseout to certain tests it asserted were generally excluded from the scope of the current enforcement discretion, including direct-to-consumer tests and tests intended for emergencies. And the agency proposes to continue enforcement discretion policies for certain types of IVDs in appropriate circumstances, including “1976-Type LDTs,” Human Leukocyte Antigen testing, and tests solely for forensic (law enforcement) purposes.

FDA seeks comment on alternative enforcement approaches, including for tests manufactured by academic medical center laboratories and small laboratories, and whether outside programs such as the New York State Department of Health Clinical Laboratory Evaluation Program should be leveraged.

Comments on the proposed rule must be submitted by December 4, 2023.