Mar 24, 2021

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) published its new Biocompatibility Assessment Resource Center this month to help companies navigate requirements relating to ISO 10993-1. Users of the website are advised to read the agency’s guidance document on evaluating and testing biocompatibility for medical devices, which was finalized in September 2020, in full. After this is complete, they are presented with a list of recommended steps along with the online resources to facilitate them. Rather than comprising a collection of all existing FDA resources on biocompatibility, the resource center provides a generalized procedural guide intended to be suitable for most companies.

Resource center provides procedural guide to biocompatibility evaluation

The steps and corresponding web pages given in the resource document are as follows:

  1. Biocompatibility Basics. This step features links to a guide on when biocompatibility information is needed, what the FDA assesses or evaluates, and how it does so, along with biocompatibility factors of interest to the FDA. Additionally featured here is a glossary of biocompatibility terms.
  2. Evaluation Endpoints. Biological endpoints tables for use in evaluation are provided here by device category as well as by contact duration period.
  3. Test Articles. This links to a page providing examples of how to document the comparison of test articles with the final proposed forms of medical devices. The content here is derived from Attachment F of the aforementioned guidance document.
  4. Test Report. This links to a guide to the preparation of the test report for biocompatibility testing, explaining what information is needed to meet FDA expectations. This content is derived from Attachment E of the biocompatibility guidance. The page also includes links to further resources on the appropriate use of consensus standards and accreditation of testing laboratories.

The resource center concludes with the advice to utilize the FDA’s Q-Submission program for device-specific questions about biocompatibility evaluation.

More about US FDA medical device regulations and biocompatibility requirements from Emergo by UL:

  • US FDA submission consulting for medical device, combination product and IVD companies
  • US FDA 510(k) registration consulting for medical device and IVD companies
  • Whitepaper: ISO 10993-1 and biocompatibility for medical devices
  • Webinar: Conducting safe in-person testing during COVID-19

Author

  • Timothy Herr

Related