Draft Guidance for Device Industry and FDA - Postmarket Surveillance

This webinar will cover FDA's Draft Guidance on Post market Surveillance Studies for device manufacturers under Section 522. It will help attendees understand the proposed changes and agency expectations regarding different stages of post market surveillance studies.

Why Should You Attend:

Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act (the act) 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 webinar will provide 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.

Areas Covered in the Webinar:

• 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 be 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 Will Benefit:

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All levels of management and departmental representatives and those who desire a better understanding with FDA’s draft guidance on postmarket surveillance and those individuals handling these activities, including: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

Instructor Profile:

David R. Dills, an independent Regulatory & Compliance Consultant with more than 24 years of experience in the FDA regulated industry, has an extensive regulatory background with Class I/II/III and IVD devices covering a breadth of therapeutic areas and managing and handling activities within the global regulatory and compliance landscape. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance and counsel on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files, addresses EU regulatory requirements regarding MDD and CE Mark and works with device registrations and approvals for the Pacific Rim, The Americas and EU. He provides assistance during inspections and with post-inspection correspondence and meetings and enjoys responding to Regulatory Authorities regarding regulatory compliance and helping with a multi-country strategy. Background encompasses broad capabilities in quality management systems, regulatory affairs, GxP auditing, interfacing with the regulatory agencies, addressing enforcement actions and mitigating compliance exposure for companies, working with Notified Bodies, AR’s and demonstrates credible experience to maximize business performance in the device arena. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory milestones.