Tracking CLSI standard changes for clinical and diagnostic laboratories

CLSI publishes standards and guidelines across laboratory medicine. Some are recognised by FDA for medical devices; recognition and edition can be checked in FDA's public database.

What CLSI publishes

CLSI states it publishes more than 300 standards, guidelines and companion products across laboratory medicine [1]. Full documents are sold by CLSI.

Check FDA recognition

FDA's Recognized Consensus Standards database lists recognised standards and editions [2]. FDA's standards programme also explains non-recognised standards and the ASCA accreditation scheme [3].

Action steps

Practical guidance for independent laboratory owners. Laboratory Vortex does not accredit, certify or audit laboratories, does not sell standards and provides no access to copyrighted standard texts.