Lexology May 10, 2024
On May 6, 2024, the Food and Drug Administration (FDA) issued the Laboratory Developed Test final rule (Final Rule), following a Proposed Rule in October 2023 that elicited over 6,000 comments to the public docket during the open comment period.
Although the Final Rule retains the same ten-word addition to the current definition of “in vitro diagnostics” (IVDs) as in the Proposed Rule, FDA changed the scope of the rule. The Proposed Rule preamble described a broad-reaching removal of enforcement discretion over the vast majority of laboratory based diagnostic tests, but the Final Rule preamble contemplates significant grandfathering, additional categories of enforcement discretion that will remain operative, and the opportunity for third-party review processes.
These significant changes to the way...
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