Compliance4All, Online Event
2016-09-07
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.
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
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 Regulatory Affairs Clinical Affairs Quality and Compliance Marketing & Sales Distributors/Authorized Representatives Consultants
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