In response to the September 2023 U.S. Food and Drug Administration’s (FDA) Laboratory Developed Tests (LDTs) proposed rule, Congress is again engaging on the issue with an LDTs House hearing. On March 21st, the House Committee on Energy and Commerce’s Health Subcommittee held a hearing on, “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” The LDTs House hearing witnesses and members of the committee focused on the need to ensure any regulation of LDTs should protect patients not only by ensuring tests are safe but by ensuring regulation is not overly burdensome such that it stifles innovation. Over the years, multiple bills have been introduced to address the regulation of LDTs including most recently the Verifying Accurate, Leading-edge, IVCT Development (VALID) Act. The VALID Act requires premarket review, with multiple exemptions, registration and listing, test design and quality requirements, labeling requirements, adverse event reporting, corrections, and removals. Grandfathered tests in use and meeting certain requirements are exempt from premarket review, labeling, test design, and quality requirements.
As previously reported ahead of the LDTs House hearing, Sen. Bill Cassidy, MD (R-La.), ranking member of the Senate Health, Education, Labor, & Pensions (HELP) Committee, issued a request for information (RFI) on March 13th seeking ways to improve the regulation of clinical tests. Responses to this request are due April 3rd. America’s Blood Centers (ABC) is developing comments and welcomes input from member blood centers.
In addition to the LDTs House hearing, the “Medical Devices; Laboratory Developed Tests” final rule is currently being reviewed by the White House Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB). The draft regulation explicitly stated 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. Along with 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. America’s Blood Centers responded to the proposed rule in comments submitted to the FDA in December 2023 that outlined four areas of concern. The rapid movement of the review process for the final rule is surprising considering the proposed rule received over 7,000 comments. FDA is required under the Administrative Procedures Act (APA) to respond to all substantive comments. If the proposed rule is finalized, litigation is anticipated that could impact implementation.
Agency IQ reported this week that ORIA, “appears to be holding regular meetings with stakeholders regarding FDA’s pending final rule on LDTs. At least seven meetings have been scheduled to date, including with the American Clinical Laboratory Association, the Association for Diagnostics and Laboratory Medicine, the Association for Molecular Pathology, ARUP Laboratories, the American College of Medical Genetics and Genomics, the Center for Science in the Public Interest, and the Children’s Hospital Association.