Zdrowie i gospodarka · 23/06/2003

FDA Revises Regulations for Premarket Review of Combination Products

The Food and Drug Administration (FDA) is revising its regulations to clarify which component within the agency will have primary jurisdiction for premarket review and regulation of combination products. This change is required by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), which mandates the establishment of an office within the FDA's Office of the Commissioner to expedite the assignment of combination products to relevant agency centers.