1. Home
  2. Medical Devices
  3. Science and Research | Medical Devices
  4. Medical Device Regulatory Science Research Programs Conducted by OSEL
  5. Biocompatibility and Toxicology Program: Research on Medical Devices, Biocompatibility, and Toxicology
  1. Medical Device Regulatory Science Research Programs Conducted by OSEL

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

Update: July 6, 2026

In July 2026, the FDA announced a new scientific study in Toxicological Sciences, a peer-reviewed journal, describing testing conducted by FDA laboratories and a toxicological risk assessment related to metals found in tampons. The study found that, while trace metals are present in tampons, the amount released during use is too small to cause harm. This study is consistent with findings from an independent systematic literature review previously commissioned by the FDA.

In October 2025, the FDA issued a draft guidance titled, Menstrual Products — Performance Testing and Labeling Recommendations. This draft guidance provides recommendations to industry to support the safety and effectiveness of menstrual products, including recommendations for evaluating these products for contaminants and promoting transparency in menstrual product ingredients. When finalized, this guidance will supersede the 2005 guidance document: Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s).

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

Medical devices that contact the human body undergo biocompatibility safety assessments. Non-clinical research undertaken to address 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 a 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 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 marketing submissions.

Biocompatibility and Toxicology Program Activities

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

  • Assessing methods for demonstrating detectability of wide physicochemical properties in non-targeted chemical analysis.
  • Improving the repeatability and reproducibility of analytical methods for chemical characterization.
  • Developing physics-based diffusion simulations to predict extractable chemicals from biomaterials.

For more information, please contact OSEL_biocomptox@fda.hhs.gov.

 

Subscribe to CDRH Science

Receive updates on regulatory science, the science of developing new tools, standards and approaches to assess the safety, efficacy, quality, and performance of medical devices and radiation-emitting products.
Back to Top