Diagnostic Tests are Generally Regulated as Devices

The Federal Food, Drug, and Cosmetic Act’s (FDCA’s) definition of “device” include “in vitro reagent” that “is intended for use in the diagnosis of a disease or other conditions . . . .” Thus, in vitro diagnostic products (IVDs) are considered devices under the FDCA, and are generally subject to FDA’s premarket and postmarket requirements, including clearance or approval, quality controls for manufacturing and distribution, and specific labeling requirements. Many genetic tests are IVDs, as are tests used in genomics, personalized medicine, and with digital health technologies to identify whether a patient is likely to benefit from a particular treatment.

FDA generally regulates IVDs according to the agency’s device risk classification system: ranging from Class I to Class III, the higher the device classification, the more FDA regulations the developer/manufacturer must follow, and the longer the statutory timeline for the device to be legally marketed. IVDs are also subject to requirements and categorization under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

FDA Once Again Has Authority Over LDTs; These Tests are Subject to the Agency’s Enforcement Discretion

Laboratory developed tests (LDTs) differ from IVDs with respect to their development, implementation, and use. IVDs are diagnostic tests that manufacturers sell to laboratories as complete “kits,” and come with all components – reagents, controls, and procedures – that a laboratory needs to perform the test. LDTs are designed, manufactured, and performed entirely within a single laboratory. This distinction presents an important legal and jurisdictional issue.

FDA first asserted its authority over LDTs in 1992, but this authority has long been challenged. In the face of these challenges, FDA did not pursue notice-and-comment rulemaking. The agency issued Draft Guidance documents in 2006, 2007, and 2014. Instead of issuing Final Guidance, FDA released a “Discussion Paper” that synthesized feedback from the 2014 Draft Guidance and follow-up meetings with stakeholders. The Discussion Paper specifically disclaimed representing any agency position. Meanwhile, FDA was largely exercising “enforcement discretion” over LDTs. This created years of confusion and uncertainty for the laboratory industry.

On August 19, 2020, the U.S. Department of Health and Human Services (HHS) determined that FDA could not assert authority over LDTs until and unless FDA pursued notice-and-comment rulemaking. While HHS’ decision was made under the circumstances of the COVID-19 public health emergency, it was not limited to LDTs related to COVID-19. Rather, HHS’ decision applied to all LDTs.

HHS’ decision appeared to bring the confusion and uncertainty for laboratories to an end. If FDA pursued notice-and-comment rulemaking, any resulting regulation would be binding, have the force of law, and apply to every entity subject to jurisdiction. None of that is true with Draft Guidance, Final Guidance, Discussion Papers, other policy statements, or enforcement discretion.

However, on November 15, 2021, HHS withdrew the August 2020 policy. HHS’ statement and an accompanying FDA press release emphasize that withdrawing the the August 2020 policy help ensure that tests for COVID-19 are accurate and reliable. But this action returns all LDTs — regardless of the health conditions for which they test — to FDA jurisdiction.


All Laboratories Must Comply with CLIA Requirement

Through CLIA, the Center for Medicare & Medicaid Services (CMS) regulates all non-research laboratory tests performed on humans in the United States. Before a laboratory can accept human specimens for testing, it must have CLIA certification. CLIA certificates vary based on the types and complexities of tests performed by the laboratory.

CMS’ objective under CLIA is to ensure that laboratories performing tests on human specimens produce accurate and reliable test results. Under the FDCA, FDA regulates devices, including IVDs, to ensure that they are reasonably safe and effective. Laboratories manufacturing or developing IVDs, must be aware of and comply with FDA and CLIA requirements. It is important to note that some requirements under these systems that are not consistent.


Christine P. Bump has Extensive Experience Regarding the Regulation of Diagnostic Tests

There remains a lot of uncertainty regarding the regulation of diagnostic tests, and how laboratories consistently comply with both FDA requirements and CLIA. Whether your test is an IVD device, an LDT, or being combined with a personalized medicine/digital health technology, you need legal counsel who is experienced at navigating these pathways. Christine P. Bump has extensive experience advising clients on the regulations, guidance, and policies applicable to laboratories and tests, and developing regulatory strategies for diagnostic tests, even when pathways are not clearly defined.

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