Get NY Non-Permitted Laboratory Test Request Approval Form 2013

¹ A very narrow exception to this requirement allows New York consumers to purchase laboratory testing on their own (“direct access testing"), but only if the test is for the same purpose as a test or collection device that has been approved by the U.S. Food and Drug Administration (“FDA”) for over-the-counter sales ...

New York State law generally allows clinical laboratories to perform tests, such as blood or urine analysis, only upon the request of an authorized HCP acting within the scope of their license.

This direct access testing option is available for tests for which a Federal Food and Drug Administration (FDA) approved test kit or collection device is available over-the-counter (OTC) without a prescription, and for tests for the same purpose.

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Background: New York State Public Health Law (Article 5, Title V, Section 574) and regulations (Part 58-1.10 (g) of 10NYCRR) require that all specimens obtained within New York State be tested by a laboratory that holds a New York State clinical laboratory permit, including test-specific approval when required.

This direct access testing option is available for tests for which a Federal Food and Drug Administration (FDA) approved test kit or collection device is available over-the-counter (OTC) without a prescription, and for tests for the same purpose.

Yes, depending on the test, you can order your own blood tests in New York. As per a law passed in 2002, New Yorkers do not need a doctor's prescription to get blood tests approved by the Food and Drug Administration (FDA) or for a collection that doesn't require a prescription.

Direct access testing (DAT) allows people to order their medical lab tests directly from a clinical laboratory without requiring a physician's lab order. DAT is also known as patient-authorized testing or direct-to-consumer testing.