ISO 10993-1 FDIS Updates: FAQ from the Panel Q&A
September 3, 2025 |
By: Christopher Parker, M.S., M.B.A., Thor Rollins and Nicholas Christiano
ISO 10993-1 guides the biological evaluation of medical devices. With the Final Draft International Standard (FDIS) approved, this update is one of the most significant in recent years.
The panel covered what is changing and how to prepare. This FAQ material was developed based on the feedback from the discussion. You can view the on-demand webinar “ISO 10993-1 Panel Discussion: Preparing for Updates in the New FDIS” here: view on-demand webinar.
Download the FAQ document here: FAQ ISO-10993-1 FDIS
Have additional questions or need a plan for ISO 10993-1? Nelson Labs Expert Advisory Services helps device and pharmaceutical teams turn requirements into clear, defensible strategies. Our specialists track regulatory trends and serve on standards committees.
For a review of your approach or a roadmap to approval, email:
[email protected].
Tagged: ISO 10993, risk assessment
Principal Biocompatibility Expert
Chris Parker is a biocompatibility expert with almost 20 years of experience working closely with medical device and combination product manufacturers to develop their biological planning and evaluation programs with global submission support. His experience lends a unique perspective of both study conduct and modeling as well as biocompatibility advisory consulting. Chris actively speaks and...
RM (NRCM)
Biocompatibility Expert
Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has published many articles...
Nicholas Christiano
Global Market Segment Leader – Biological Safety
Nicholas Christiano is the Global Market Segment Lead for Biological Safety at Nelson Labs. He is responsible for driving strategic growth, leadership, and market direction across the biocompatibility and extractables & leachables (E&L) testing segments. He has over 12 years of experience in the biocompatibility field for medical devices. Prior to working for Nelson Labs, Nicholas held scientific roles within the biocompatibility segment at a major orthopedic medical device manufacturer and within pharmaceutical drug development in the oncology space. He is a part of standards development with AAMI, and he participates in multiple working groups as well as supporting the development and round robin efforts toward multiple in vitro alternatives.
