lunes, 26 de septiembre de 2016

Interested in Receiving Input Regarding Private Payer Coverage for your Medical Device?

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FDA’s Center for Devices and Radiological Health (CDRH) has been exploring opportunities to improve patient access to safe and effective medical devices by shortening the time between FDA approval or clearance and device coverage.  CDRH recognizes that the clinical evidence required for FDA approval or clearance can be different than the evidence required to obtain coverage.  This difference may delay coverage decisions if the medical device sponsors are unaware of the coverage data requirements, and/or need to conduct another trial or gather additional evidence.  These potential delays in coverage decisions may ultimately delay patient access to innovative medical devices. 
In February 2016, CDRH’s Payer Communication Task Force (PCTF), part of CDRH Innovation, highlighted a voluntary opportunity for private payer coverage organizations and health technology assessment groups (HTAS) to express interest in providing input to medical device sponsors on clinical trial design or other plans for gathering clinical evidence needed to support coverage decisions.  
Today, we have updated our website to share the names of the private payers and HTAs who have expressed interest  in attending a Pre-Submission meeting to learn more about new devices and provide input on the clinical evidence needed to support coverage decisions.   We will periodically update this list as other private payers and HTAs express interest in participating.  
Please note, participation in this opportunity is voluntary for both medical device sponsors and coverage organizations. Participation will not change the evidentiary standards the FDA uses for decision-making.
If you have any questions about this voluntary opportunity, please contact the PCTF at
Food and Drug Administration
Center for Devices and Radiological Health

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