The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced today that it is now offering an electronic Biocompatibility Assessment Resource Center intended to provide guidance for addressing and evaluating the biocompatibility of medical devices.
This website, designed for medical device manufacturers, presents a clear step-wise approach that aligns with the recommendations established in Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process,” the FDA’s Biocompatibility Guidance on Use of ISO 10993-1 and other related guidance documents. This online resource outlines general steps for device manufacturers to follow, accompanied by links to glossaries and other useful resources.
1. Biocompatibility Basics
- Provides information on the “when, what and how” associated with the evaluation of biocompatibility
- Explains the biocompatibility factors of interest to the FDA
2. Evaluation Endpoints
- Supplies biocompatibility evaluation endpoint tables by device category and contact duration
3. Test Articles
- Provides examples to demonstrate potential approaches to documenting test article comparisons to proposed, finished medical devices and how other approaches may be acceptable
4. Test Reports
- Outlines critical information recommended as part of the final test reports included in FDA submissions
The FDA welcomes general biocompatibility questions regarding this effort that may be sent directly to CDHR at CDRH.Biocomp@fda.hhs.gov.
How Can NAMSA Help?
NAMSA is the pioneer of the medical device testing industry and continues to serve as the global marketplace leader for reliable, proven testing services. Our teams of Regulatory, Quality, Preclinical and Clinical Research Associates have many years of experience working for, and with, the FDA and other global regulatory entities.
Offering a wide range of Biological Safety solutions, we work with Sponsors to ensure all medical device development programs are compliant, while also focusing on the most efficient means possible to complete necessary tests.
Nicole Bronson, BIS
Nicole R. Bronson B.I.S currently serves as a Biological Safety Specialist at NAMSA. Nicole has 16 years’ experience in the medical device industry with a strong background in biological safety. She began her career at NAMSA working in the toxicology laboratory and has since held roles such as GLP Study Director and Technical Advisor. Nicole has broad expertise and knowledge of medical device regulations and expectations from the U.S. FDA and other global regulatory entities. Nicole holds a Bachelor of Science Degree from Lourdes College.