Use of laboratory developed tests in clinical and research laboratories for screening, diagnosis, or treatment of clinical conditions

Designation Number:
Z316.8
Standard Type:
Consensus SDO Standard
Standard Development Activity:
New Standard
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

The standard is intended to provide guidance on the validation of laboratory developed tests in clinical and research labs to be used for screening, diagnosis, or treatment of clinical conditions.  The standard will provide guidance and requirements on the performance characteristics to validate the quality of the tests in the areas of pathology, microbiology, clinical chemistry, and genetics.

Project need:

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