title: Strategic planning for U.S. premarket approval submissions.
abstract: The United States premarket approval (PMA) process is costly and time-consuming and differs in important ways from the CE-marking process. This article discusses the importance of strategic planning for submission of a PMA and the issues that should be considered, which can lead to a reduction in the time and cost involved.
authors.affiliation: Donawa Consulting srl, Rome, Italy. medonawa@donawa.com
authors.forename: Maria
authors.initials: M
authors.lastname: Donawa
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D004867:Equipment Design / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards; D010934:Planning Techniques; D014481:United States; D014486:United States Food and Drug Administration