U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. Medical Devices
  3. Products and Medical Procedures
  4. In Vitro Diagnostics
  5. Laboratory Developed Tests
  6. Laboratory Developed Tests: FAQs
  7. Definitions and General Oversight: Laboratory Developed Tests FAQs
  1. Laboratory Developed Tests: FAQs

Definitions and General Oversight: Laboratory Developed Tests FAQs

General

What is an LDT?

IVD Classification

Laboratories

Laboratory Changes

Registration & Listing

Inspections & Audits

Back to Top