Comprehensive Test Approval Policy and Submission Guidelines - Subsection 58-1. 10(g) of Part 58

Sep 29, 2026

Comprehensive Test Approval Policy and Submission Guidelines from the New York State Department of Health’s Wadsworth Center set requirements for laboratories performing technical procedures. It explains which assays require specific Department review and approval, and outlines that only validated performance may be used, with appropriate permit categories, on-site survey readiness, personnel/proficiency testing, and related documentation. The application procedures cover FDA-approved assays and standard methods, including how to submit via eCLEP and when additional validation data is required, plus exception handling for genetic testing molecular.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages4

Reading Time10 min

AccessFree to download

Comprehensive Test Approval Policy and Submission Guidelines

Application Procedures

FDA-approved assays

Standard Method

Modifications to FDA cleared/approved or NYS-approved assays

STATE OF NEW YORK DEPARTMENT OF HEALTH Wadsworth Center The Governor Nelson A. Rockefeller Empire State Plaza P.O. Box 509 Albany, New York, 12201-0509 COMPREHENSIVE TEST APPROVAL POLICY AND SUBMISSION GUIDELINES Subsection 58-1. 10(g) of Part 58 of Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York states that all technical procedures employed in a laboratory shall be of proven reliability and generally accepted by leading authorities in the specialties of laboratory medicine and/or approved by the Department. A laboratory can perform only those assays for which the performance characteristics have been established and validated, or if already established (typically by a manufacturer) verified at the site where the assay will be performed. The laboratory must also hold the appropriate permit category for the test and must meet all other requirements related to on-site survey, personnel and proficiency testing. This guidance document will describe the types of tests that require specific review and approval from the Department and provide forms and instructions for submitting test approval materials. Due to the variety of test methods available, ancillary requirements, notification forms and checklists for submissions in certain specialties are included as appendices to this [document.](document. Contact Program staff at clepval@health.state.ny.us)[ Contact Program staff at](document. Contact Program staff at clepval@health.state.ny.us)[ ](document. Contact Program staff at clepval@health.state.ny.us)[clepval@health.state.ny.us](document. Contact Program staff at clepval@health.state.ny.us) for questions, or for guidance on situations not explained here. APPLICATION PROCEDURES Description of Assay/Test How to Apply Requirements / Guidance | FDA-approved assays
Assays cleared (510k), approved (PMA), or exempted by the United States Food and Drug Administration (FDA) that have not been modified to change the procedure or the intended use. FDA clearance or approval status can be found at FDA’s Medical Devices website. A separate FDA site lists Approved Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays.
This includes Investigational Use Only (IUO)-labeled tests ONLY when utilized under a specific FDA Investigational Device Exemption (IDE) . | If your laboratory already holds a NYS permit, submit the test addition viaeCLEP. You may also make an Add Category request via eCLEP if the laboratory does not hold the appropriate category.
If you are not certain which permit category is required for an assay, you can refer to the category/analyte list included in the Guide to Program Requirements and Services available on our website, or contact program staff for assistance.
Laboratories applying for an initial permit may include FDA-approved assays on the test list included in the initial permit application, no additional forms are necessary.
*Exception: Genetic Testing – Molecular, refer to Application for Assay Approval in Genetic TestingMolecular | Laboratories holding a permit in the required category may perform FDAapproved assays once they have submitted the test addition notification via eCLEP and have met their own quality management systems requirements. Laboratories applying for a category, or applying for an initial permit, may begin testing once the permit has been amended or issued. Verification data will be reviewed during the initial survey (for new permits and categories) or during the next on-site survey (for laboratories already holding a permit) . The Department may, based on survey findings or other concerns about the performance of the assay, request additional documentation and verification data. Refer to requirements in the Clinical Laboratory Standards of Practice (Examination Practices Validation/VAL S5) . | | --- | --- | --- | | Standard Method
A standard method is defined as anassay that has an established r

FAQs

Which assays require Department review and approval under the policy?

The guidance describes types of tests that require specific Department review and approval and provides submission forms and instructions for approval materials.

How should a laboratory submit an added test category for FDA-approved assays?

If the laboratory already holds a NYS permit, it should submit the test addition via eCLEP, and request an add category via eCLEP if the laboratory does not hold the appropriate category.

What happens if an assay is determined not to qualify as a standard method?

If review determines the assay does not qualify as a standard method, additional documentation and validation data may be requested for Department review.

Sep 29, 2026

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