As part of the Medical Device User Fee Amendments of 2012, FDA agreed to post annually a list of prioritized device guidance documents that the Agency intends to publish within the next 12 months. This year, the FDA designated an “A-list” of final and draft guidance documents including many impactful recommendations that have altered how medical devices are regulated. Ultimately, these changes in the regulations have affected every medical device manufacturer this year. We will cover some of the more crucial guidance documents that were recently released and discuss how FDA’s recommendation may be significant to your company.

Important updates have emerged from the ISO/TC-194 working group, responsible for the upkeep of ISO 10993. Comprised of representatives from regulatory agencies, major medical device manufacturers, contract research laboratories, and consultants, the working group met in June to discuss the direction they will take the ISO 10993 standard in the future.

This webinar will provide insight into the basic thoughts and ideas expressed by FDA, Europe, Japan, and China in these meetings. Discussion will also include the committee’s thoughts regarding,

• Cytotoxicity testing and the varying perspectives each regulatory agency has on this method
• How systemic toxicity testing is changing
• The new ISO 10993-18
• How the committee plans to strengthen the general concepts in ISO 10993-1