Proposal for Cardiovascular Registries

The FDA filed a Notice of Public Meeting and Request for Comments regarding what it is calling the "International Consortium of Cardiovascular Registries."  The purpose is to discuss the development of the registry and to garner feedback from interested parties on the following topics:

  • The role of registry consortia in postmarket surveillance
  • Goals of the International Consortium of Cardiovascular Registries,
  • Lessons learned from the development of the ICOR,
  • Development of an international consortium of transcatheter valve registries as a pilot phase,
  • Analysis of near- and long-term outcomes reported through registries, and
  • Discussion of capabilities, challenges, and limitations of existing transcatheter valve registries.

The FDA indicates that the effort will be modeled on the International Consortium of Orthopedic Registries (ICOR) and will begin with transcatheter valve therapy devices and procedures.

The The meeting will be held on April 22, 2013, from 8 a.m. to 5 p.m. at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002.

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