FDA Classification of Computerized Labor Monitors

FDA published notice in the Federal Register on 24-April-07 that it has classified Computerized Labor Monitoring Systems as Class II devices and requires 510(k)s for them (product code NPB). The notice identifies a list of risks and mitigations associated with such devices. The full register notice is at the link provided.
As a basis for not considering these Class III devices FDA published a special control guidance document for such devices. This is available in a separate item in the softwarecpr website library.