Life Sciences

New labor monitoring devices must meet guidance specs

Device Regulation Alert: Safety, Compliance and Reimbursement News, June 4, 2007

Any company submitting pre-market notification for a computerized labor monitoring system must address specific issues described in FDA special control guidance released in April. The term "computerized labor monitoring system" refers to a device that measures cervical dilation and fetal head descent during labor using a monitor and ultrasound transducers. Effective May 24, any company submitting premarket notification for such a device must demonstrate the device meets the guidance recommendations or otherwise assure the FDA of the device's safety and effectiveness.

At the same time the FDA issued the guidance, it published a Federal Register notice classifying labor monitoring devices in class II (special control) because special controls "provide reasonable assurance of the safety and effectiveness of the device for its intended use." The FDA noted in the Federal Register notice announcing the classification that placing the device in class II would alleviate the cost of premarket approval and could allow small companies producing such a labor monitoring system to compete in the marketplace.

The FDA guidance identified the following risks that should be addressed in a company's premarket notification documents:

  • Injury to the baby or mother

  • Electrical hazards

  • Tissue damage due to heat of the ultrasound

  • "Electromagnetic interference and electrostatic discharge"

  • Patient care problems due to decisions based on the device's reporting

  • "Adverse tissue reaction"

  • Infection of baby or mother

    The guidance recommends ways to mitigate these risks. Manufacturers must discuss in their premarket notification how they have addressed these risks but only have to show that their device meets the recommendations in the guidance or "in some other way provides equivalent assurance of safety and effectiveness."

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