FDA finalizes lab developed test rule over industry opposition

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MedTech Dive

  • The Food and Drug Administration on Monday released a final rule strengthening its authority over laboratory developed tests, or LDTs, advancing a policy that has drawn fierce opposition from healthcare industry groups.
  • The rule amends agency regulations to make explicit that in vitro diagnostics are devices under the Federal Food, Drug and Cosmetic Act, including when the manufacturer of the diagnostic is a laboratory.
  • The FDA said it will phase out its enforcement discretion approach for LDTs so that in vitro diagnostics manufactured by a laboratory will generally fall under the same enforcement policy as other tests.

Critics argue the FDA’s plan to increase oversight of LDTs will slow development of cutting-edge diagnostics. Under the new rule, most LDTs would be regulated as medical devices, subject to pre-market review as other in…
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