Key Take Away:
This webinar will address the latest FDA guidance requirements and expectations and expound on why tracking methods must provide certain critical information about the location of a tracked device.
The Food and Drug Administration Modernization Act (FDAMA) requires that manufacturers track certain devices when the agency orders them to do so.
Tracking is intended to facilitate notification and recall in the event a device presents a serious risk to health that requires prompt attention. The tracking provisions enacted by SMDA required mandatory tracking even if FDA did not issue an order. Specifically, section 519(e), as added by SMDA, required manufacturers to track if they were registered with FDA under section 510 of the act and engaged in the manufacturer of a device if its failure would be reasonably likely to have serious adverse health consequences, and if that device was either a permanently implantable device or a life-sustaining or life-supporting device used outside a device user facility.
Section 519(e), as revised by FDAMA, states the agency may require tracking for a class II or class III devices: (A) the failure of which would be reasonably likely to have serious adverse health consequences; or (B) which is intended to be implanted in the human body for more than one year; or (C) which is a life sustaining or life supporting device used outside a device user facility.
Why Should You Attend:
This webinar will address the latest FDA guidance requirements and expectations and expound on why tracking methods must provide certain critical information about the location of a tracked device. Plus, FDA understands that manufacturers will have different tracking methods and procedures.
Areas Covered In This Webinar:
• Review the key provisions in the updated FDA guidance on medical device tracking
• Understand the regulatory expectations for device tracking
• Identify new terms and criteria
• Understand the statutory criteria and what changed
• FDA has issued orders to manufacturers who are required to track various implantable devices
• Define the additional guidance factors to be considered when determining whether a tracking order should be issued
• Understand why tracking methods are subject to FDA inspection
• When does tracking end?
• Identify what information to report and your responsibilities
• Understand the impact with user facilities and patient issues
Who Will Benefit:
• All levels of Management and Departmental Representatives and those who desire a better understanding or a "refresh" overview of the Medical Device Tracking process and FDA’s latest expectations
• Regulatory Affairs Personnel
• Clinical Affairs Personnel
• Quality and Compliance Personnel
• Marketing & Sales Professionals
• Distributors/Authorized Representatives
David R Dills
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.
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