FDA LDT Guidance Delayed
Regulator misses its own deadline to make sure it gets it right
William Aryitey |
Laboratory developed tests (LDTs) in the US have long been under the jurisdiction of the Clinical Laboratory Improvement Law – which covers laboratory regulations in general. From vitamin assays to tests for genetic mutations, as long as the in vitro LDTs were designed, manufactured, and used within a single laboratory, there were no regulatory issues. That is, until the FDA got involved…
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