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| Session 9A: Regulatory and Biocompatibility Issues for Medical Device Manufacturers | ||||
| Location: Governors Hall I & V (Radisson Riverfront Hotel) | ||||
| (Please check final room assignments on-site). | ||||
| Session Description: SESSION BACKGROUND:
Engineers and scientists in the medical device business must have an understanding of the latest changes and developments with the FDA approval process, biocompatibility of new alloys, and biocompatibility test methods.
SESSION FOCUS:
This session will address the latest issues regarding FDA approval of cyanocrylate tissue adhesive materials, the biocompatibility of new titanium-silver alloys for dental applications, corrosion resistance and cytotoxity of stainless steels containing nickel, and new in-vivo biocompatibility test methods.
SESSION TAKEAWAYS:
This session will provide an improved understanding of the FDA medical device regulatory system and the latest developments with biocompatibility testing. | ||||
| Editor: | Mr. Donald F. Gibbons 3M Company, North Oaks, MN | |||
| Session Chair: | Mr. Donald F Gibbons 3M Company, North Oaks, MN | |||
| 8:30 AM | SES 9A.1 | Lead Presentation: U.S. FDA Perspective on the Regulations on Medical Device Tissue Adhesive Materials such as Cyanoacrylate Adhesives in Clinical Applications | ||
| 9:00 AM | Medical Device Engineering Outsourcing in a Regulated Environment | |||
| 9:20 AM | Regulatory Strategies in Technology Implementation | |||
| 9:40 AM | POST 1.26 | Biocompatibility Study of Ingot and Powder Processed Stainless Steel Alloys for Implant Applications | ||
| 10:00 AM | 10:00 - 10:30 a.m. • Break • Registration Lobby | |||