Lexology May 1, 2024
On April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory developed tests (LDTs). Set to be officially published on May 6, this rule follows more than a decade of efforts both by FDA to clarify the regulatory status of LDTs, and after several years of deliberations in Congress regarding reform to the regulatory framework of in vitro diagnostics (IVDs), including LDTs.
FDA published the proposed rule on October 3, 2023, and received approximately 6,500 comments. In response to these comments, FDA did not change its amendments to the regulation itself but is extending enforcement discretion to multiple categories of LDTs and making minor changes...
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