title: US regulation of Advertising and promotional materials.
abstract: Medical device manufacturers do not always properly control the development of new or modified promotional labelling and advertising materials. This lack of control can lead to unexpected regulatory problems. This article discusses United States requirements for these materials and the type of controls that companies should exercise.
authors.affiliation: Donawa Consulting, Rome, Italy. medonawa@donawa.com
authors.forename: Maria
authors.initials: M
authors.lastname: Donawa
mesh_terms: D000329:Advertising / Q000331:legislation & jurisprudence*; D004864:Equipment and Supplies; D014481:United States; D014486:United States Food and Drug Administration