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FDA Postmarket Surveillance Draft Guidance and Implications for Industry



 
Our Price: $395.00

Product Code: WB-7143
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Includes 1 hour Windows Media Video File and PowerPoint presentations for immediate download.


In early 2015 the Brookings Institution, a nonprofit think-tank committed to independent research and innovative policy, released an article outlining a seven-year plan to develop and execute a National Medical Device Postmarket Surveillance System (MDS). The Brookings Institution was commissioned by the FDA to develop the draft proposal citing a need to replace outdated monitoring methods and provide enhanced data demonstrating the safety and benefits of medical devices. Under the proposal, opportunities and strategies for increasing the efficiency and value of postmarket evidence development to support decision-makers across health care system are outlined. A thorough understanding of these potential strategies and uses of data will provide device manufacturers with a proactive approach for managing risks and ensuring postmarket safety and compliance.
  • US Device Postmarket Surveillance: Past, present and future
  • Vision for a National Medical Devise System for postmarket evidence development
  • Proposal effects on other stakeholders (patients, payors, providers, etc.)


Speaker:
Gregory W. Daniel, PhD, MPH
Managing Director for Evidence Development & Innovation, Center for Health Policy
Fellow, Economic Studies

Brookings Institution


Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
  • Regulatory Affairs
  • Postmarket Surveillance
  • Quality Assurance

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