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What Really Changed: A Look at the Updated FDA Guidance Document for ISO 10993-1

December 5, 2023

1:00 pm ET

In September 2023, the FDA released a new revision to its guidance document on the use of ISO 10993-1, which focuses on the evaluation and testing of medical devices within a risk management process. The first question to ask when a new revision is released is, “What changed?” Once that question is answered, a follow up question is, “How does that impact my device and/or submission?”

This 60-minute webinar will review the changes to the FDA’s guidance document — including a look at the information provided in the FDA’s explanatory webinar given in October 2023 — as well as how to assess the revision’s impact on different situations. Speakers also will review some of the unchanged information to highlight lessons learned on the practical application of the guidance document.

Topics will include:

  • Changes found in the new revision of the FDA guidance document
  • How to assess the impact to individual situations
  • Lessons learned through practical application of the document

An audience Q&A session will follow the technical presentation.

Learn more about the presenters below.

Audrey Turley

Audrey Turley

Director of Expert Advisory Services & Biocompatibility Expert

Audrey Turley has over 25 years of experience working in research, laboratory, and test design functions in the medical device industry. She is a biocompatibility expert, having performed all the in vitro tests offered at Nelson Labs, which include cytotoxicity (MEM and agar overlay), hemolysis (PTT, PT, complement activation, blood circulation, ASTM, and NIH methods),...

Helin Räägel, PhD

Helin Räägel, PhD

Biocompatibility Expert

Dr. Räägel is a globally recognized expert in medical device biocompatibility. She has extensive expertise in writing biological evaluations and assessments for regulatory submissions. These documents focus on using a risk-based approach in defining the path to evaluating medical devices, with US FDA and EU regulatory bodies as the primary audience. She works closely with...