Devices

In Vitro Diagnostic Device Characteristics Guidance

FDA has issued a guidance, Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses, to facilitate study designs to establish the performance characteristics of in vitro diagnostic devices intended for the detection or detection and differentiation of human papillomaviruses. The document says the devices are used in conjunction with cervical cytology to aid in screening for cervical cancer or as first-line primary cervical cancer screening devices.

The guidance says it provides detailed information on the types of studies FDA recommends to support a PMA for the devices. It recommends that sponsors contact the agency before beginning studies to discuss specific study proposals and performance goals for the device.

Contents include Introduction, Background, Scope, Risks to Health, Device Description, Test Methodology, Establishing Performance Characteristics, and References, with an Appendix on statistical analysis.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome