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New NYSDOH Policy for Risk-based Evaluation of Laboratory Developed Tests Begins November 14, 2016

CLEP News

Monday, October 17, 2016

This three-tiered, risk-based model for the review and approval of laboratory developed tests (LDT) applies to all laboratories holding a NYS clinical laboratory permit in the appropriate category of testing and applies to all assays that require submission as directed on the Test Approval page.

Laboratory-developed tests that are conditionally approved or qualify for conditional approval (i.e. a package that is considered to be complete has been received by close of business (4:30 PM E.D.T.) November 11, 2016  from a laboratory holding a permit in the relevant category) prior to the date of implementation of this policy will continue to hold such approval.

Risk-based Laboratory Developed Test Approval Policy

Risk Attestation Form

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