MedTech Dive April 29, 2024
Susan Kelly

Risks associated with the tests have increased, requiring greater oversight to protect patients, the agency contends.

Dive Brief:

  • The Food and Drug Administration released a final rule on Monday strengthening its authority over laboratory developed tests (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 IVD 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.

Dive Insight:

Critics argue...

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Topics: FDA, Govt Agencies, Provider
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