Beyond the US submisson process

Med Device Technol. 2004 Apr;15(3):30-2.

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.

MeSH terms

  • Commerce / legislation & jurisprudence*
  • Commerce / standards
  • Consumer Product Safety / legislation & jurisprudence
  • Device Approval / legislation & jurisprudence*
  • Device Approval / standards
  • Equipment and Supplies / standards*
  • Guidelines as Topic
  • Product Labeling / legislation & jurisprudence*
  • Product Labeling / standards
  • Product Surveillance, Postmarketing / methods
  • Product Surveillance, Postmarketing / standards*
  • Radiation Protection / legislation & jurisprudence
  • United States