• Post-Market Surveillance: FDA's "Sentinel Initiative" and Related CMS Rulemaking
  • June 20, 2008 | Authors: Catherine A. Hurley; Areta L. Kupchyk
  • Law Firm: Reed Smith LLP - Washington Office
  • On May 22, 2008, the Food and Drug Administration ("FDA") announced plans for what it is calling the "Sentinel System"--a new, national electronic health information surveillance system to track the performance and safety of medical products once they are on the market.