The “Medical Devices; Laboratory Developed Tests” (LDTs) final rule review is underway way the White House Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB). The LDTs final rule review notification was preceded by draft regulation previously announced by the U.S. Food Drug Administration (FDA) in a proposed rule released in September 2023 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. In addition to this change, the agency proposed a policy under which the FDA intends to provide greater oversight of 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.
Ahead of the LDTs final rule review, America’s Blood Centers responded to the proposed rule in comments submitted to the FDA in December 2023 that outlined four areas of concern including:
- “LDTs developed by blood establishments are not associated with the type of safety concerns FDA is addressing with this rule;
- many LDTs developed in a blood center’s lab are 1976-Type LDTs and/or are developed with a high level of standardization across institutions;
- blood centers’ LDTs are comparable to Human Leukocyte Antigen (HLA) tests. FDA should apply general enforcement discretion to all HLA tests and blood center’s LDTs; [and]
- the impact [of the LDT regulation] on patient access; [explaining that] blood centers’ LDTs are extremely safe and effective under the current framework and do not have a history of safety issues. Blood centers and hospitals are required to report adverse events to FDA. The safety record of these tests is well-documented in this reporting system, and a mechanism exists to resolve any safety issues that are potentially identified.”
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, with the LDTs final rule review in progress, regarding reforms to diagnostics regulations including LDTs. “In the past, Congress has considered proposals to bring needed reforms to diagnostics regulation. These efforts have been unsuccessful and have resulted in missed opportunities to implement substantive updates to both regulatory frameworks. To further guide ongoing discussion of these matters, I welcome your insights on the following topics, specifically addressing the actions Congress should pursue to meet the challenge of ensuring patient access to timely and advanced diagnostics.” Responses are due by April 3rd. Reps. Cathy McMorris Rodgers (R-Wash.), chair of the House Energy and Commerce Committee, and Brett Guthrie (R-Ky.), chair of the Subcommittee on Health, announced that a hearing is scheduled for March 21st to, “discuss the FDA’s proposed rule to regulate LDTs and alternative approaches to diagnostic regulation.”
With the LDTs final rule review underway, ARUP Laboratories, a national reference laboratory, conducted a survey of its customer contacts and announced results of a survey, that included more than 500 responses, in a news release that included a link to preprint (non-peer reviewed) paper. Findings included, “[a] total of 83.9 percent of respondents believe the proposed rule will negatively impact their laboratories; nearly 61 percent of participants said they would likely remove tests from their laboratory menus if the proposed rule is enacted, and an additional one-third of respondents are not yet sure what they would do.”
OIRA is, “the U.S. Government’s central authority for the review of Executive Branch regulations, approval of Government information collections, establishment of Government statistical practices, and coordination of Federal privacy policy.” It is the office where the LDTs final rule review is currently taking place.