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Medical Device Tracking Latest FDA Update and Expectations Webinar by GlobalCompliancePanel

11/19/2013 10:00 AM - 11:00 AM

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

Regulatory Affairs

Clinical Affairs

Quality and Compliance

Marketing & Sales

Distributors/Authorized Representatives


David R. Dills, Regulatory Affairs & Compliance Consultant currently provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems.

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

USA Phone:800-447-9407

Fax: 302-288-6884

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