Fierce Biotech April 29, 2024
The FDA has finalized its regulatory rule that aims to bring laboratory-developed tests more in-line with how the agency oversees other diagnostics.
At its heart, the 528-page final rule (PDF) looks to make clear that in vitro diagnostic tests are to be considered medical devices like any other under the Federal Food, Drug & Cosmetic Act, the decades-old law that grants the agency its authorities.
In the past, the FDA made allowances for tests that were developed for limited use within a laboratory, and did not require them to clear the agency’s review process. Commonly referred to as LDTs, they were originally categorized as a product with lower risks compared to mass-marketed diagnostic kits, because they were typically produced in...
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