title: Premarket approval supplement pathway: do we know what we are getting?
authors.forename: Sarah Y
authors.initials: SY
authors.lastname: Zheng
authors.forename: Rita F
authors.initials: RF
authors.lastname: Redberg
mesh_terms: D018795:Device Approval; D004869:Equipment Safety; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration