FDA’s Draft Guidance for Laboratory-Developed Tests

Get Permission

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
http://www.regulations.gov/#!home). ■


Related Articles

Molecular Pathologists vs the FDA: Proposed Regulation of Laboratory-Developed Tests Sparks Debate

The packed ballroom looked like a plenary session at any big medical research meeting. But on the dais were representatives of the Food and Drug Administration (FDA), the subject was the Agency’s proposed regulation of laboratory-developed tests, and the attendees who lined up to ask questions for...