The volume of combination products or submissions with jurisdictional ambiguity coming through FDA has remained relatively constant in the past five to six years, but the number of formal consultations between FDA product review centers has doubled during the same period.
Human Factors Questions Drive Rise In FDA Inter-Center Consults
Formal consultations between FDA's product centers are becoming more frequent, and they are often triggered by questions about human factors issues, says Office of Combination Products Director Thinh Nguyen.