Overview: 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. This session 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 the Session:
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: This webinar will provide an overview and guidance to device manufacturers involved in medical device tracking activities. Employees who will benefit include:
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
Quality and Compliance
Marketing & Sales