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Clinical Laboratory Evaluation Program

Direct Access Testing

On September 24, 2002 Governor Pataki signed a bill amending the Public Health Law by adding Section 576b. Clinical laboratories may now offer certain tests directly to individuals without the intervention of a medical professional. This direct-access testing option is restricted to tests that have been approved by the Food and Drug Administration for direct, over the counter (OTC) sale to consumers.

Tests such as blood glucose and pregnancy tests are among those eligible for direct access. A complete list is available at http://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfIVD/Search.cfm

The Clinical Laboratory Evaluation Program has developed guidance to laboratories that plan on offering laboratory tests direct to consumers.

Guidance Documents

The guidance documents are available as Adobe Portable Document Format (PDF) files.
The Adobe Acrobat Reader software is required to view and print these documents. [HELP with PDF files. Requests for the document in an alternate format can be requested by sending an e-mail note to CLEP@health.ny.gov.