Regulation of Laboratory Developed Tests

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Scope of Reviews What type of assays require review and approval? Assays not expressly approved (PMA), cleared (510k), or exempted by the FDA, including: •Commercialized test kits variously labeled as Research Use Only (RUO) or Investigational Use Only (IUO) •Laboratory Developed Tests (LDTs) that include the use of reagents prepared by the lab and/or analyte-specific reagents (ASRs) •FDA cleared/approved tests that have been modified from their intended use
Scope of Reviews Comprehensive Test Approval Policy and Guidelines Description of Assays/Tests Instructions on how to apply General Requirements for Assay Validation Guidance documents for specific scientific disciplines •Cellular Immunology •Forensic Identity •Genetic Testing-Molecular •Molecular Microbiology •Oncology-Molecular •Toxicology •Trace Elements •Cytogenetics under development (http://www.wadsworth.org/labcert/TestApproval/forms/Submission_Guidelines_Policy.pdf)
Page 1 and 2: Regulation of Laboratory Developed
Page 3 and 4: Wadsworth Center Clinical Laborator
Page 5 and 6: Part 58-1.10(g) of 10 NYCRR Assay A
Page 7: Assay Approval In the past 10 years
Page 11 and 12: Scope of Reviews Molecular Microbio
Page 19 and 20: Inter-assay reproducibility Scope o
Page 21 and 22: Assay Verification Scope of Reviews

Regulation of Laboratory Developed Tests

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