The FDA issued a guidance classifying computerized labor monitoring systems as Class II, or special controls.
The document lists the health risks associated with these systems and describes measures required to address these risks.
Following the effective date of the final rule classifying the device, any firm submitting premarket notification for this product will need to address the issues covered in the guidance document.
Computerized labor monitoring systems are intended to continuously measure cervical dilation and fetal head descent and provide a display indicating the progress of labor.
The guidance, "Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems," can be accessed at www.fda.gov/OHRMS/DOCKETS/98fr/2007d-0122-gdl0001.pdf.