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FDA downclassifies software for contraception

  • Posted by: inetika
  • Category: GLOBAL NEWS

The US Food and Drug Administration (FDA) has reclassified software applications for contraception as Class II medical devices with special controls, making them exempt from premarket notification requirements. The Agency has moved this type of medical device type automatic Class III into Class II (special controls) because it has determined that the change “will provide a reasonable assurance of safety and effectiveness” for patients.

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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