U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Science and Research (Medical Devices)
  4. CDRH Research Programs
  5. Biocompatibility Assessment
  1. CDRH Research Programs

Biocompatibility Assessment

Contact:

Alan Hood, PhD; alan.hood@fda.hhs.gov

Summary

or medical devices to be determined safe, they must include a biocompatibility evaluation to address the risks posed by the potential presence of harmful chemicals. Numerous examples of compounds leaching from medical devices have been documented. While animal studies have historically been used to predict long-term safety and effectiveness, tests such as those for carcinogenicity, reproductive toxicity, and systemic toxicity are expensive, time-consuming, utilize large numbers of laboratory animals, and sometimes do not provide results that are easily translatable into a human health-based risk assessment. There is a need to modernize biocompatibility evaluation of medical devices by integrating chemical characterization, alternative toxicology test methods, computational modeling, and emerging toxicological risk assessment tools to reduce the regulatory review time, and reduce the need for animal testing by the sponsors, thereby reducing the time needed to test and bring devices to market. Examples of current research include:

  • assessment of biocompatibility and health risk of medical device materials, such as color additives, nickel, phthalates, contaminants, manufacturing residues, and degradation products;
  • use of 3D skin tissue constructs as an alternative in vitro model to identify skin irritants in extracts of medical devices.

It is expected that research in these areas will make more transparent and predictable the requirements for non-clinical and possibly clinical assessments in the regulatory process.

Image of In vitro biological evaluation of degradants from bioresorbable medical device polymers


In vitro biological evaluation of degradants from bioresorbable medical device polymers


Missing media.
Image of medical device components with color additives

Medical device components with color additives.

Current funding sources:

FDA Critical Path Initiative
NSF-FDA Scholar in Residence Program

Personnel

Research Staff:
Rosalie Elespuru, Ph.D.
Peter Goering, Ph.D.
Alan Hood, Ph.D.
Irada Isayeva, Ph.D.
Berk Oktem, Ph.D.
Diego Rua, Ph.D.
Hainsworth Shin, Ph.D.
Shelby Skoog, Ph.D.
Eric Sussman, Ph.D.
Xing Tang, Ph.D.
Samanthi Wickramasekara, Ph.D.
Steve Wood, Ph.D.
Jiwen Zheng, Ph.D.

Research Fellows:
Paul Turner, Ph.D.
Keaton Nahan, Ph.D.

FDA Collaborators
Molly Ghosh, Ph,D. (CDRH/OPEQ)
Jennifer Goode, B.E. (CDRH/OPEQ)

External Collaborators
University of Maryland
University of Michigan

Relevant Standards & Guidances
ISO 10993 – Biological Evaluation of Medical Devices

CDRH Biocompatibility Guidance Document – “Use of International Standard ISO 10993-1,"Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"(published 2016)

Resource facilities:
FDA Advanced Characterization Facility
Mass Spectrometry Shared Use Facility

Selected peer-review publications:

  1. De Jong WH et al. Round robin study to evaluate the reconstructed human epidermis (RhE) model as an in vitro skin irritation test for detection of irritant activity in medical device extracts. Toxicol In Vitro. 2018 Aug;50:439-449. doi: 10.1016/j.tiv.2018.01.001.
  2. Savery LC, et al. Deriving a provisional tolerable intake for intravenous exposure to silver nanoparticles released from medical devices.disclaimer icon Regul Toxicol Pharmacol. 2017 Apr;85:108-118. doi: 10.1016/j.yrtph.2017.01.007.
  3. Skoog SA, et al. Effects of nanotopography on the in vitro hemocompatibility evaluation of nanocrystalline diamond coatings. J Biomed Materials Res: Part A 105(1):253-264, 2017. doi: 10.1002/jbm.a.35872. 
  4. Dearfield KL, et al. Next generation testing strategy for assessment of genomic damage: A conceptual framework and considerations: Next Generation Testing Strategy for Assessment of Genomic Damagedisclaimer icon. Environ Mol Mutagen. 2017 Jun;58(5):264-283. doi: 10.1002/em.22045. 
  5. Chandrasekar V et al. Conservative Exposure Predictions for Rapid Risk Assessment of Phase-Separated Additives in Medical Device Polymersdisclaimer icon. Annals of Biomedical Engineering. 2018; 46:14-24. doi: 10.1007/s10439-017-1931-4