title: New US agent requirements.
abstract: The United States (US) Food and Drug Administration (FDA) has recently published a final rule that will require medical device establishments located outside the US and whose products are imported into the US, to register with FDA and identify a US agent. This article discusses the new establishment registration and US agent requirements.
authors.affiliation: donawa@srd.it
authors.forename: Maria
authors.initials: M
authors.lastname: Donawa
mesh_terms: D003132:Commerce / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004864:Equipment and Supplies / Q000592:standards*; D006801:Humans; D012042:Registries; D014481:United States; D014486:United States Food and Drug Administration