FDA Regulation of Tampons and Pads
The U.S. Food and Drug Administration (FDA) classifies menstrual tampons as Class II (non-significant risk) medical devices and pads as Class I medical devices. This means manufacturers are required to submit to FDA a detailed risk assessment of the device components, the design, and test results. If questions were raised about safety, manufacturers are required to provide additional information to the FDA.
The FDA data submission process includes:
- Detailed description of the products including its composition.
- Detailed risk assessments.
- Assessments of human safety, such as irritation and allergy, in accordance with internationally-recognized consensus standards.
- Confirmation the microbiological safety of tampons.
- Evaluation of the intended labeling to assure women have access to the proper usage and safety information.