FDA’s Draft Guidance for Laboratory-Developed Tests

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The FDA’s proposed regulatory framework is based on a test’s level of risk to the patient.

  • Premarket approvals would be required of the tests in the highest-risk category within a year of the final guidance; that would include tests for which there is already an FDA-approved equivalent.
  • For subsequent high-risk tests and moderate-risk tests, premarket approvals would be phased in over a 9-year period. Priorities and risk status would be determined through a public process.
  • Premarket approvals would not be required for traditional tests, tests for rare diseases, and those that serve an unmet need, including tests for which there is no FDA-approved equivalent, as long as these tests met the FDA’s definition of a laboratory-developed test.
  • Laboratories would be required to notify the FDA of existing and new tests and to begin reporting adverse events.

The FDA has issued two documents: one describing the proposed regulatory framework and the other focusing on the notification process. Comments on each may be submitted by February 2, 2015 (visit!home). ■


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