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How the New FDA Guidance on ISO 10993 Could Possibly Affect You

Date: August 21, 2013
Time: 01:00 PM EDT
Duration: 60 minutes including Q&A
Sponsored by

About the sponsor, click here.

About the webinar

In April of 2013 the FDA released a draft guidance on using ISO 10993 for biocompatibility. This draft is intended to replace the #G95-1 document on the current thinking and application of biocompatibility testing for medical devices. In the webinar we will cover three areas of the new document:

1. Summary of ideas that are currently practices by the FDA but this is the first instance that they are put in writing

2. Concepts that can be used for justifying testing plans, and

3. New ideas that are not current thinking with the FDA that could change how you are testing.
Presenters Include:

Thor Rollins
In-vivo Biocompatibility Section Leader
Nelson Laboratories, Inc.


Shana Leonard
Executive Editor
UBM Canon MedTech Group

For biographies, click here.