• Feature ArticlesFeature Articles

    The 'Catch-Up' 510(k) - A Submission Often Overlooked

    This article discusses "catch-up" 510(k) submissions, circumstances under which a "catch-up" 510(k) submission should be considered, content and timing of such a submission and procedural recommendations for this submission type. Background The majority of medical devices are brought to market in the United States through the 510(k) pathway. A 510(k) clearance is based on FDA's review and concurrence with the submitter's substantial equivalence determination, allowin...
  • Regulatory NewsRegulatory News

    Perspectives on the FDASIA Health IT Report and Public Workshop

    On 7 April 2014, a Food and Drug Administration Safety and Innovation Act ( FDASIA )-mandated workgroup issued its strategy and regulatory framework document on health IT to Congress. 1 The workgroup is comprised of representatives from the US Food and Drug Administration (FDA), the Federal Communications Commission (FCC) and the Office of the National Coordinator for Health Information Technology (ONC). A public workshop was held 13–15 May 2014 to discuss the pr...