Understanding of latest FDA guidance requirements and expectations related to medical device tracking and what are the new changes.This medical device tracking webinar training will address the latest FDA guidance requirements and expectations and expound on why and what are the information, the tracking methods must provide about the location of a tracked device. We will also discuss the role and responsibilities and the impact with user facilities and patient issues.
Areas Covered in the Seminar:- 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 are required to track various implantable devices - FDA has issued orders to manufacturers
- What are 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
- Consultants
