Medical Device Tracking: Latest FDA Update and Expectations 2016 is a webinar that covers topics such as:
- 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
Medical Device Tracking: Latest FDA Update and Expectations 2016 is intended for:
- 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
