FDA Postmarket Surveillance Draft Guidance and Implications for Industry

1 Hour Video | Gregory W. Daniel, Brookings Institution

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 The Brookings Institution was commissioned by the FDA to develop the draft proposal citing a need to replace outdated monitoring methods and provide enhanced data demonstrating the safety and benefits of medical devices.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 Device System for postmarket evidence development
  • Proposal effects on other stakeholders (patients, payors, providers, etc.)

 

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

brookings (3)
Gregory W. Daniel, PhD, MPH
Managing Director for Evidence Development & Innovation, Center for Health Policy
Fellow, Economic Studies
Brookings Institution

Dr. Gregory Daniel is a Fellow in Economic Studies and Managing Director for Evidence Development and Innovation in the Center for Health Policy at Brookings. In this position, Dr. Daniel leads the Center’s pharmaceutical and medical device policy portfolio that includes developing strategies for better post-market safety surveillance and comparative effectiveness research, improving regulatory science, fostering practical steps for implementing expedited drug and device development and review tools, improving biomedical innovation, and supporting payment reform. Dr. Daniel is also a senior advisor to the Reagan-Udall Foundation for the FDA.

Prior to joining Brookings, Dr. Daniel was the Vice President of Government and Academic Research at HealthCore, Inc., a research subsidiary of Anthem, Inc. At HealthCore, he led a division responsible for research in the areas of pharmacoepidemiology, drug, vaccine, and biologic safety evaluations, comparative effectiveness research, and health economics and outcomes research. His research has utilized electronic health insurance claims data integrated with clinical data including laboratory results, electronic hospital data, paper-based and electronic medical record data, and registries. Dr. Daniel is a registered pharmacist and holds a PhD in Pharmaceutical Economics, Policy, and Outcomes with a minor in Epidemiology from the University of Arizona, an MPH specializing in biostatistics, an MS in Pharmaceutical Administration, and a BS in Pharmacy, all from The Ohio State University.


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1 Hour and 10 Minute Video | Bethany J. Hills, Epstein Becker Green

 

In April of 2014 the FDA has released a long-awaited draft guidance proposing a new program which provides an expedited approval pathway for high-risk medical devices that are intended to treat serious conditions whose needs are unmet by current technology. In addition to the Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions or the “EAP” program, the FDA simultaneously released draft guidance entitled Balancing Premarket and Postmarket Data Collections for Devices Subject to PMA. The document outlines provisions specifying when data can be collected after product approval and FDA enforcement actions should these requirements not be met. It can be difficult for manufacturers to enroll patients in a trial once the product has been approved, therefore, the primary challenge for device companies will come when trying to meet the post-market data collection requirements in the FDA’s time frame.

 

  • In-depth overview of EAP program and eligibility criteria
  • Program benefits for industry and patients
  • Clarifying manufacturer post-approval data collect policies
  • Enforcement actions for non-compliance

 

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
  • Pre-Market Approval
  • Post-Market Surveillance
  • Regulatory Submissions

 

 

This webinar has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for up to 1.5 credits towards a participant’s RAC recertification upon full completion.

 

 

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Bethany J. Hills
Member of the Firm
Epstein Becker Green

 

 

Bethany J. Hills is a Member of the Firm in the Health Care and Life Sciences practice, in the New York office of Epstein Becker Green. She counsels life science, medical device, and health care provider businesses on a broad range of reimbursement, regulatory, and compliance matters.