title: Beyond the US submisson process.
abstract: After expending considerable effort to comply with United States (US) marketing authorisation regulations, a company launched its first product on the US market. Unfortunately, the company failed to comply with other applicable US regulations, which led to a delay in the US product introduction and FDA postmarketing enforcement actions against the product. This article discusses ways that companies can prevent this from happening.
authors.affiliation: Donawa & Associates Ltd, Rome, Italy. donawa@srd.it
authors.forename: Maria
authors.initials: M
authors.lastname: Donawa
mesh_terms: D003132:Commerce / Q000331:legislation & jurisprudence* / Q000592:standards; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards*; D017408:Guidelines as Topic; D011356:Product Labeling / Q000331:legislation & jurisprudence* / Q000592:standards; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards*; D011835:Radiation Protection / Q000331:legislation & jurisprudence; D014481:United States