2011-Regulatory Issues Surrounding Approval of Antimicrobial Agents on Biomedical Products in USA

Regulatory Issues Surrounding Approval of Antimicrobial Agents on Biomedical Products in USA


Min Yao, Ph.D.
Medline Industries, Inc


簡報大綱
1. EPA
2. FDA
3. FDA Definition on Medical Device
4. Antimicrobial Products without
5. Public Health Claims
6. EPA Treated Item Exemption
7. Public Health Claims
8. FDA Device Classification
9. FDA requirements on Antimicrobials
10.Biocompatibility
11.Summary