Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices
Instructor:
Cheryl Wagoner
Product ID: 703585
- Duration: 60 Min
Why Should You Attend:
In April 2013, FDA published a new draft guidance entitled Use of International Standard ISO -10993, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.” This guidance is intended to replace the existing Blue Book Memorandum #G95-1 Use of International Standards ISO-10993, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing” dated May 1, 1995.
The webinar will discuss the primary points of the new guidance as well as any differences between the new guidance and the 1995 memorandum.
Further, it will also address other related fields such as test selection as per the FDA modified matrix, general biocompatibility testing considerations, test reports and various other test specific considerations.
Areas Covered in the webinar:
- Background of the new draft guidance
- Test selection of the ISO standard
- Test selection as per the FDA modified matrix
- General biocompatibility testing considerations
- Test specific considerations
- Labeling
- Test Reports
- Examples
- Comparison of the draft guidance with the 1995 memorandum
Who Will Benefit:
This webinar will benefit the following personnel in the medical device industry:
- Regulatory managers
- Project managers
- Staff involved with regulatory filings
- Product development managers
Cheryl Wagoner, has 20 years of experience in quality assurance and regulatory affairs. She currently is the principal consultant/owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Previously, she has held various positions in quality, regulatory, clinical and compliance in the medical device and pharmaceutical industries.
Cheryl is a member of Regulatory Affairs Professionals (RAPS), and the Association for the Advancement of Medical Instrumentation (AAMI). She completed the RAPS Executive Development Program at the Kellogg School of Management.
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