Medical Device Tracking: Latest FDA Update and Expectations 2016

Key Topics

• Regulatory expectations for device tracking
• Key provisions in the updated FDA guidance on medical device tracking
• The statutory criteria and what changed
• Identify new terms and criteria
• Additional guidance factors to be considered when determining whether a tracking order should be issued
• FDA has issued orders to manufacturers who are required to track various implantable devices
• When does tracking end?
• Why tracking methods are subject to FDA inspection
• The impact with user facilities and patient issues
• What information to report and your responsibilities

Who should Attend

• Regulatory Affairs
• 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
• Clinical Affairs
• Distributors/Authorized Representatives
• Marketing & Sales
• Consultants