Overview
On April 29, 2024, the US Food and Drug Administration (FDA) issued a long-awaited final rule asserting its authority to regulate laboratory-developed tests (LDTs) as medical devices. If the rule goes into effect, there will be major impacts on clinical laboratories offering LDTs.
During this webinar, we reviewed the final rule, explored what happens next and covered critical implications for stakeholders in the diagnostics industry.
Top takeaways included:
- LDTs generally will be subject to FDA’s existing regulatory framework for medical devices by making explicit that in vitro diagnostic products (IVDs) are devices under the Food Drug & Cosmetic Act, including when the manufacturer is a laboratory. Enforcement discretion would generally phase-out in five stages over a four-year period starting May 6, 2024.
- Some tests will be eligible for some form of continued enforcement discretion (i.e., “grandfathering”), and businesses should analyze whether their LDTs fall into any scope of exception. For example, the following tests are exempt from certain – but not all – medical device requirements:
- LDTs approved by New York State.
- LDTs first marketed prior to May 6, 2024, which are not modified, or are modified only in certain limited ways.
- LDTs manufactured within an integrated healthcare system to meet unmet needs of patients receiving care within that healthcare system.
- Furthermore, the following types of tests are exempt from all medical device requirements:
- Pre-1976-Type LDTs.
- Certain human leukocyte antigen tests performed in a single laboratory.
- Tests intended solely for forensic purposes.
- Tests for public health surveillance (where results are not reported back to patients or providers).
- Tests performed and manufactured within the US Department of Defense or the US Departments of Veterans Affairs.
- However, FDA retains the ability to take enforcement action against any “violative” LDT at any time – even those “grandfathered” as described above. FDA intends to “request” labeling from laboratories for such LDTs (including information on test performance and a summary of validation data) and “anticipates” that laboratory manufacturers will alert FDA regarding potential problems with their competitors’ tests once performance information is made publicly available. Either of these pieces of information could potentially lead to agency enforcement action, depending on the agency’s assessment of the relevant facts and circumstances.
- Outstanding questions remain, such as how the final rule will change Congress’s and the industry’s viewpoint on VALID, which tests the FDA will down-classify, and the outcome of pending legal challenges to the final rule under the Administrative Procedure Act.
