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., RAC
New Product Development Manager Medline Industries, Inc


簡報大綱
What are antimicrobial agents?
Easy Identification
FDA Definition on Medical Device
Antimicrobial Products without Public Health Claims
EPA Treated Item Exemption
Public Health Claims
FDA Device Classification
FDA requirements on Antimicrobials
Summary