Today, the U.S. Food and Drug Administration (FDA) announced laboratory developed tests regulation in an upcoming proposed rule to be published (October 3rd) in the Federal Register. The laboratory developed tests regulation explicitly states that in vitro diagnostic products (IVDs) are medical devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. In addition to this change, the agency proposed a policy under which the FDA intends to provide greater oversight of laboratory developed tests (LDTs), through a phaseout of its general enforcement discretion approach to LDTs, so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs. Historically, the FDA has exercised enforcement discretion over most LDTs, meaning the agency generally has not enforced applicable requirements with respect to most LDTs.
A 60-day comment period will follow the publication of the proposed rule on laboratory developed tests regulation in the Federal Register on October 3rd with comments due by December 4th. The agency also explained that it is aware of arguments that the medical expertise of laboratorians or requirements under clinical laboratory improvement amendments (CLIA) already provide adequate oversight of IVDs offered as LDTs. However, FDA noted that their review of the evidence indicates otherwise, and suggests that under the current scheme, the healthcare community lacks adequate assurances about the safety and effectiveness of IVDs offered as LDTs. Additionally, although laboratories that offer LDTs are also subject to CLIA, which is primarily administered by the Centers for Medicare & Medicaid Services (CMS), CLIA is not a substitute for FDA oversight.
While the agency’s approach described in the proposed rule would phaseout its general enforcement discretion approach for most LDTs, the FDA does not intend to sweep in certain tests that were excluded from the general enforcement discretion approach, as reflected in compliance patterns, multiple public FDA actions and communications, or both. These tests include those that are intended as blood donor screening or human cells, tissues, and cellular and tissue-based products (HCT/Ps) donor screening tests required for infectious disease testing under 21 CFR 610.40 and 1271.80(c), respectively, or for determination of blood group and Rh factors required under 21 CFR 640.5.
The FDA further explained that under the cited regulations, a blood or HCT/P establishment must not use a test for the purposes listed here unless the test is licensed, approved, or cleared by FDA for such use. Blood and HCT/P establishments must register with FDA and are subject to FDA inspection. The agency also added that the general enforcement discretion approach for LDTs has never applied to these tests because these tests are a critical part of the overall process of ensuring the safety of blood and blood components and HCT/Ps by preventing infectious disease transmission and incompatible blood transfusions which can have life-threatening consequences. Based on FDA’s experience, establishments have been generally complying with these requirements, and they are not proposing to change that approach.
America’s Blood Centers (ABC) in consultation with the ABC QA Blood Regulatory Review and the Scientific, Medical, and Technical Committees, and the ABC Policy Council will further review the rule to assess the impact on the policies and procedures of blood centers. ABC also plans to submit comments on the proposed rule and encourages member blood centers to send their own letters on the draft guidance to FDA.
The proposed rule on laboratory developed tests regulation was previously announced as forthcoming in the June when the Office of Information and Regulatory Affairs (OIRA) published Spring 2023 Unified Agenda of Federal Regulatory and Deregulatory Actions.
(Sources: FDA News Release, 9/29/23; FDA Proposed Rule, 10/3/23; MCN 23-082, 9/29/23)