Draft Guidance for Device Industry and FDA - Postmarket Surveillance
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This webinar will provide an overview and guidance to firms that are either going through or preparing to go postmarket surveillance activities.
This guidance document is being distributed for comment purposes only and will be of benefit for medical device manufacturers and the document was issued on August 16, 2011.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) 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.
Areas Covered in the Session:
Who Will Benefit:
- 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
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 financial disclosure by clinical investigators, including:
- Regulatory Affairs
- Clinical Affairs
- Quality and Compliance
- Marketing & Sales
- Distributors/Authorized Representatives
- Legal Counsel
David R. Dills, is Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO) to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry.
He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM's/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations.
Mr. Dills most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations.
He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products.
David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific.
He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones and on minimizing delays due to noncompliance and regulatory risk.
He has worked directly with global manufacturers and sponsors engaged in compliance remediation activities and services involving enforcement actions and customer generated compliance events, inspection preparation, among other regulatory and compliance responsibilities.