The Lyme Disease Association, Inc. (LDA) formulated a response to FDA to be included in its comment period on its testing Guidance which will affect specialty lab Lyme tests. Groups who wanted to support the position taken by the LDA were able to join in on the letter. Letter was submitted with 73 groups signed on.
BRIEF HISTORY: FDA is moving forward in the process of finalizing its new Laboratory Developed Test (LDT) Guidance proposal. The proposal would move LDTs from under the jurisdiction of Clinical Laboratory Improvement Amendment (CLIA) regulated by Medicare & Medicaid Services to under the jurisdiction of the Food & Drug Administration (FDA). The FDA now regulates non-LDT lab tests under “medical devices,” and “approves” or “clears” tests. Non LDTs are tests which are sold to other laboratories while LDTs are generally tests which are developed and used in one lab, commonly called specialty labs.
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