FDA Puts Multiplex Test Instrumentation into Class II
03/10/2005
Federal Register Final rule: FDA is classifying instrumentation for clinical multiplex test systems into Class II (special controls) FDA is also making available a guidance document entitled Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems. It includes recommendations for validation of performance characteristics and recommendations for product labeling. To download this guidance, click here. To view this final rule, click here.
