FDA to Conduct Tampon Study

2024-09-20 20:38

While the pilot study found evidence of metals in tampons, it did not test whether or not the metals are released from the tampon during use. It also did not test for metals being absorbent into the vaginal lining or entering the bloodstream during use. FDA has commissioned an independent literature review and initiated an internal bench laboratory study to evaluate metals in tampons.”

The FDA’s laboratory study will measure the amount of metals that come out of tampons under conditions that more closely mimic normal use. These initiatives will enable the FDA to complete a risk assessment of metals contained in tampons, based on a worst-case scenario of metal exposure. The FDA will communicate findings from the literature review and lab testing publicly when they are available and have been peer reviewed. The FDA will also continue monitoring these devices as part of its total product lifecycle approach to medical devices.

The agency also emphasized that all tampons cleared by the FDA have already been evaluated as described in the guidance document Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) and was determined to meet FDA premarket requirements.