Draft Guidance for Device Industry and FDA - Postmarket Surveillance

Duration: 60 Minutes
This guidance document is being distributed for comment purposes only and will be of benefit for medical device manufacturers and the document was issued on August 16, 2011. Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act (the act).
Postmarket surveillance
Instructor: David R Dills
Product ID: 500075
Is one means by which the Food and Drug Administration (FDA) can obtain additional safety and/or effectiveness data for a device after it has been cleared through the premarket notification (510(k)) process or approved through the premarket approval application (PMA), humanitarian device exemption (HDE), or product development plan (PDP) process, when it is necessary to protect the public health. Postmarket surveillance is not a substitute for obtaining the necessary premarket information to support 510(k) clearance or PMA, HDE, or PDP approval. This guidance document is intended to assist those subject to section 522 postmarket surveillance imposed by FDA by providing: an overview of section 522 of the act, procedural information on how to fulfill 522 obligations, and recommendations on the format, content, and review of postmarket surveillance study submissions. Substantive additions to the 2006 version of this guidance document will be addressed.

Objectives of the Presentation:
  • Review proposed changes
  • Explain the legal background and overview of statutory criteria
  • Considerations regarding pediatric population provisions
  • Understand expectations for postmarket surveillance study duration
  • Describe the postmarket surveillance process and identification of issue
  • Why an order for postmarket surveillance will issued under section 522
  • Learn why postmarket surveillance study plans are reviewed as an original submission and its amendments until the plan is approved
  • Determine the elements to Include in a Postmarket Surveillance Study Plan
  • Understand why FDA may order postmarket surveillance to address a wide variety of device-related public health questions
  • Current expectations for different stages of Postmarket Surveillance Study Reports
  • Why happens if you fail to complete a Postmarket Surveillance Study
Who can Benefit: This webinar will provide an overview and guidance to firms that are either going through or preparing to go postmarket surveillance activities. The employees who will benefit include: All levels of management and departmental representatives and those who desire a better understanding with FDA’s draft guidance on postmarket surveillance and those individuals handling these activities, including:
  • Regulatory Affairs
  • Clinical Affairs
  • Investigators
  • Quality and Compliance
  • Marketing & Sales
  • Distributors/Authorized Representatives
  • Legal Counsel
  • Consultants
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Instructor Profile:
David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVD's, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA and IDE submissions, serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. Background encompasses broad capabilities in regulatory and compliance oversight and governance, regulatory and GxP training, and compliance with MEDDEV/MDD/IVDD Directives. Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EU and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.
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