title: Foreign Establishment Registration and United States agent requirements.
abstract: In 2002 the Food and Drug Administration implemented new requirements for foreign companies that import medical devices into the United States (US). This article reviews the Establishment Registration requirements and discusses the new Establishment Registration and US Agent requirements for non-US companies.
authors.affiliation: Medical Device Consultants Inc., North Attleboro, Massachusetts, USA.
authors.forename: Cynthia J M
authors.initials: CJ
authors.lastname: Nolte
authors.forename: Mary
authors.initials: M
authors.lastname: McNamara-Cullinane
mesh_terms: D020811:Biomedical Technology; D001709:Biotechnology / Q000191:economics / Q000331:legislation & jurisprudence*; D003132:Commerce / Q000331:legislation & jurisprudence*; D004864:Equipment and Supplies / Q000191:economics; D005161:Facility Regulation and Control / Q000331:legislation & jurisprudence*; D006801:Humans; D007221:Industry / Q000331:legislation & jurisprudence; D007391:International Cooperation / Q000331:legislation & jurisprudence*; D011358:Product Surveillance, Postmarketing; D012042:Registries; D014481:United States; D014486:United States Food and Drug Administration / Q000191:economics / Q000331:legislation & jurisprudence*