FDA Regulation of Combination Products
July 7, 2015 - Online event CA USCompliance4all
support@compliance4All.com
Phone:8004479407
Fax:302-288-6884
Attend this 60 minutes presentation to gain a fundamental understanding of FDA’s regulation of Combination Products. A combination product is assigned to an Agency Center or alternative organizational component that will have primary jurisdiction for its premarket review and regulation. Under section 503(g)(1) of the Act, assignment to a center with primary jurisdiction, or a lead center, is based on a determination of the "primary mode of action" (PMOA) of the combination product. Areas Covered in the Session: Definition of combination product FDA Regulatory Pathways Primary Mode of Action User Fees http://www.compliance4all.com/control/w_product/~product_id=500418LIVE/