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2013 to Be a Big Year for Biocompatibility; Nelson Labs Participates in Potential Updates
Date:9/16/2013

SALT LAKE CITY, Sept. 16, 2013 /PRNewswire/ -- 2013 is shaping up to be a big year for biocompatibility and Nelson Laboratories (www.nelsonlabs.com) is in the thick of it with its involvement in the ISO 10993 Working Group, participation in round-robin testing of a potential in vitro replacement for Rabbit Irritation Testing and leading in the discussion regarding biocompatibility guidance on the horizon from FDA.

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New FDA Draft Guidance

FDA placed into a draft guidance document its summary of ideas regarding biocompatibility and possible changes that could eventually replace FDA G-95 Blue Book Memorandum #G95-1 on biocompatibility.

"The draft document has been out since April and widely available," said Thor Rollins, Biocompatibility Expert at Nelson Laboratories. "It has not been formally released, but there is a lot of buzz about the document. Many people are having a difficult time interpreting what is different, what has changed and what kind of impact it will have moving forward. Though only a draft, it does give insight on what FDA is thinking."

The document is in three categories:

  • Summary of Ideas – a summary of ideas FDA has expressed for a few years.
  • Justification Ideas – FDA spells out general ideas of how to justify biocompatibility choices. FDA has never done that before.
  • Possible Impacts – shows possible impacts never before seen regarding biocompatibility.(Read More)

ISO 10993 Working Group

Nelson Laboratories recently participated in the ISO 10993 Working Group's Italy Sessions where
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