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FDA Biological Evaluation Guidance


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On June 16, 2016 the FDA officially released the much anticipated Guidance Document Titled: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff.

This guidance document discusses the following topics:

  • Use of risk assessments for biocompatibility evaluations for a proposed medical device
  • Use of ISO 10993-1 and the FDA-modified matrix (Attachment A) to determine the relevant biocompatibility endpoints for an evaluation
  • General biocompatibility testing considerations, including test article preparation
  • Specific considerations for the following testing: cytotoxicity, sensitization, hemocompatibility, pyrogenicity, implantation, genotoxicity, carcinogenicity, reproductive and developmental toxicity, and degradation assessments
  • Chemical assessment recommendations
  • Considerations for labeling devices as “-free”

This guidance also includes helpful attachments such as Recommended Master File content, biocompatibility evaluation flow chart,  and recommended contents for a biocompatibility test report.

At NAMSA we are committed to shortening your product time to market with our MRO Approach, and as your trusted advisor and partner, we are dedicated to giving you the most current and accurate education.  Given this very important document release and upcoming effectiveness date, we are hosting a complimentary live webinar Tuesday June 21, 2016. 

In this NAMSA webinar you will learn

  • What are the updates since the 2013 Draft Guidance
  • What do these changes mean to you and your medical device evaluations
  • When is guidance taking effect, and how should you prepare
  • How can early adoption of these updates save you time and money in your FDA submissions
  • How can you engage the FDA to answer questions

The guidance document can be found here for your reference:


Speaker Bio:

Don Pohl

Manager, Biological Safety & Validation

Don holds a Bachelor’s degree from Ohio State University. He has over 20 years of experience in the pre-clinical evaluation of medical devices for biological safety. During his career, he has held a variety of positions ranging from laboratory supervision/management, GLP Study Director, Technical Specialist for Laboratory Information Management System, Technical Specialist and project manager for Biological safety and biological risk assessment consultation. He has specific expertise in the evaluation process outlined in ISO 10993-1 as well as the expectations of the USFDA and other countries in their interpretation of the biological safety evaluation of medical devices.