Summary of article from Polsinelli, by Suzanne Bassett, Michael Gaba:
The FDA’s Final Rule regulating Laboratory-Developed Tests (LDTs) was published on May 6, 2024, and is expected to take effect in 60 days. The rule expands the definition of in vitro diagnostics (IVDs) to include LDTs and will significantly alter the regulatory landscape for LDTs, impacting manufacturers, patients, and healthcare providers. Despite over 6,500 comments, no substantial changes were made from the Proposed Rule to the Final Rule, but there were significant adjustments to enforcement discretion policies. The rule is expected to face legal challenges and potential legislative action from Congress. The Final Rule applies to all IVDs offered as LDTs, regardless of whether the test meets the traditional definition.