FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

FDA Reclassifies Contraception Software as Class II (Special Controls)

March 11, 2019
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The FDA reclassified software applications for contraception as Class II medical devices with special controls, making them exempt from premarket notification requirements.

The agency moved the device type from automatic Class III into Class II (special controls) because it determined that the change “will provide a reasonable assurance of safety and effectiveness.”

The special controls include clinical performance testing to show the software’s effectiveness and human factors testing to show users can correctly use the application based on the directions for use. Other controls include software verification, validation and a hazard analysis.

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