FDA Brief: Week of Feb 22, 2016



Proposal for Joint FDA-Coverage Organization Meeting to discuss Evidentiary Standards for Regulatory Review and Reimbursement



  • 2011-2015: FDA-CMS Pilot Initiative for parallel discussion and review of device premarket clearance (by FDA) and National Coverage Determination (by CMS)
  • 2016:  FDA intends to provide a mechanism to get early payer input on evidentiary needs to streamline process from FDA Approval  to Payer Coverage
  • Use CDRH’s Pre-Submission program as a forum for joint discussion between Sponsor, FDA and Coverage organization


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