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  1. Medical Device Regulatory Science Research Programs Conducted by OSEL

Biocompatibility and Toxicology Program: Research on Medical Devices, Biocompatibility, and Toxicology

December 23, 2024

As part of continuing efforts to assess the safety of tampons, in September 2024, the FDA commissioned an independent, systematic, literature review and initiated a laboratory study on metals in tampon materials. The literature review is now complete, and the FDA is sharing the report.

Although limitations were identified in the literature review, as is common, the findings did not identify safety concerns associated with tampon use and contaminant exposure. The FDA continues to recommend FDA-cleared tampons as a safe option for use as a menstrual product.

The Literature Review
The purpose of the literature review was to determine the available evidence on contaminants in tampons and their related health effects. It included nine published articles that evaluated a variety of different contaminants in tampons, including metals, phthalates, parabens, bisphenols, volatile organic compounds (VOCs), dioxins, and triclocarban. 

There are limitations related to the methods used in the studies that were reviewed. In addition, none of the studies reviewed address how much, if any, of the contaminants identified are released from the tampon or absorbed through the vagina.  Although limited, the available evidence continues to support the FDA’s conclusion that tampons remain a safe menstrual product option.

Additional Study
The FDA’s internal bench laboratory study, already underway, intends to determine if metals from tampon materials are released or absorbed in the body. Specifically, the study will measure the amount of metals that may be released from tampon materials under conditions that more closely mimic normal use. The FDA will share findings from the laboratory testing when they are complete and have been peer reviewed.

The ongoing laboratory study will better enable the FDA to complete a risk assessment of metals contained in tampon materials, based on a worst-case scenario of metal exposure.

FDA Actions
The FDA committed to further evaluating the safety of tampons because an outside study published in 2024 found low levels of metals in tampons during laboratory testing. While that study reported metals in some tampons, it did not test whether metals are released from tampons when used or whether they were absorbed into the vaginal lining or getting into the bloodstream.

Regulatory Background
Before tampons can be legally sold in the U.S., they must meet FDA requirements for safety and effectiveness. Manufacturers must test tampons and the materials the tampon is made of before, during, and after manufacturing. Also, before tampons are allowed onto the market, manufacturers must perform biocompatibility and other safety testing. The FDA reviews the results of the testing prior to market authorization.

Any tampon currently cleared by the FDA has 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 performance requirements.

The FDA will also continue monitoring these devices as part of its total product lifecycle approach to medical devices.

The Biocompatibility and Toxicology Program in the FDA’s Center for Devices and Radiological Health (CDRH) conducts regulatory science research on the interactions between medical devices and the human body to help ensure patient access to innovative devices that are safe and effective. This is one of 20 research programs in CDRH’s Office of Science and Engineering Laboratories (OSEL).

Biocompatibility, Toxicology, and Medical Devices

All medical devices that contact the human body undergo biocompatibility safety assessments prior to market release. Pre-clinical research undertaken to address pre-market questions raised about the biocompatibility of medical devices is multidisciplinary and encompasses the use of biological evaluation and toxicological risk assessment technologies including novel in vitro, ex vivo/in vivo testing, and computational/in silico methodologies.

The Biocompatibility and Toxicology Program (BTP) addresses the biological and toxicological safety of the broad spectrum of medical devices currently on the market and emergent technologies (such as novel materials). The regulatory science efforts of the BTP are cross-cutting and span multiple medical device product lines to support the regulatory activities across all OPEQ offices. Specifically, the scope of this program is focused on promoting the acceptance/qualification of methods/tools (such as New Approach Methodologies [NAMs]*) or development of international standards or guidance for:

  • evaluating biocompatibility (i.e., biological) endpoints and
  • evaluating/estimating toxicological risk.

* Note: NAMs include a broad range of "alternative methods" such as in vitro, in chemico, in silico (such as, computational, bioinformatics), and systems biology approaches. In vivo methods can also be considered NAMs when they improve predictivity, shift studies to phylogenetically lower animals, or help replace, reduce, and refine animal use (that is, the 3Rs).

Regulatory Science Gaps and Challenges

The major regulatory science gaps and challenges that drive the Biocompatibility and Toxicology Program are:

  • Insufficient New Alternative Methodologies (NAMs) validated/qualified for biocompatibility assessment of medical devices.
  • A need for tools/methods (such as web-based/computational, guide) that facilitate and improve consistency of toxicological risk assessments for medical devices.
  • Inadequate guidelines for evaluating biocompatibility of medical devices throughout their device lifetime.

Through regulatory science research, the Biocompatibility and Toxicology Program seeks to fill these knowledge gaps in order to improve and advance safety assessment approaches that are least burdensome to the medical device industry without compromising patient safety. To achieve this goal, the Biocompatibility and Toxicology Program evaluates new, as well as refines current, testing approaches to help harmonize methods for biocompatibility evaluation of medical devices and promote further consistency in the regulatory review of pre-market submissions.

Biocompatibility and Toxicology Program Activities

Currently, the Biocompatibility and Toxicology Program focuses on regulatory science research in the following areas:

  • Evaluating the performance of in vitro test methods (such as reconstructed human epidermis [RhE] irritation test) with the objective to support their regulatory acceptance for assessing the biological risk(s) of medical devices.
  • Establishing toxicological risk assessment tools (such as based on ISO 10993-17) to standardize calculations and promote uniformity in the toxicological risk assessment of medical devices.

For more information, email OSEL_biocomptox@fda.hhs.gov

 

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