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1 1 (October 11, 2024)

handle is hein.crs/goveqyf0001 and id is 1 raw text is: FDA Regulation of Tampons October 11, 2024 An August 2024 study led by researchers at Columbia University evaluated the concentration of 16 different metals in multiple brands of tampons and reported detecting measurable concentrations of all 16 metals. The authors concluded that using tampons may be a potential source of metal exposure, although the study did not evaluate if the metals were released by the product or absorbed by the user. Research in this area is limited. In response, FDA has announced that it is undertaking a review of metals in tampons to help support its regulation of these products. Specifically, FDA plans to commission an independent literature review to learn more about data available regarding to what extent chemicals may be present in tampons, in addition to possible health effects. The agency also plans a laboratory study of tampons in typical use situations, to try to determine the extent to which metal may be released during normal use. These findings have focused attention on FDA's oversight oftampons, which are regulated as devices by the agency. Specifically, questions have been raised about the sufficiency of labeling requirements for these products (i.e., transparency around intentionally added ingredients in the product), as well as the adequacy of premarket testing requirements for potential contaminants and elimination of those contaminants. This Insight provides an overview of FDA's current regulation of tampons. FDA Regulation FDA regulates medical devices generally by the risk they pose to the consumer and what is known about the device type, and therefore what is known about measures that may be taken to mitigate risk. The agency classifies low-risk devices as Class I, moderate-risk devices as Class II, and high-risk devices as Class III. Regulatory control increases by class, and for devices, regulatory control must be sufficient to provide a reasonable assurance of safety and effectiveness. This is partially determined by an analysis of the benefit of using the device as compared with the risk of using the device. FDA regulates tampons as Class II medical devices, subject to general regulatory controls, including 510(k) premarket notification, and special controls, specifically, performance standards. General controls include, for example, Quality System regulation (device good-manufacturing practices), establishment registration and device listing, Medical Device Reporting (MDR, device adverse event reporting), labeling, recall authority, and premarket notification. To meet the 510(k) premarket notification requirement, the device manufacturer provides to FDA a submission demonstrating that its device is substantially equivalent to a legally marketed predicate device, and receives clearance to market the Congressional Research Service https://crsreports.congress.gov IN12441 CRS INSIGHT Prepared for Members and Committees of Congress

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