What does FDA require for Medical Devices Manufacturers to Do When Filing an Adverse Event Report (MDR)
Overview:
As an experienced FDA medical device investigator, many firms have failed to fully incorporate the requirements of 21 CFR 803 when establishing and implementing their reporting procedures.
This webinar will assist the medial device manufacturer with determining what FDA requirements must be incorporated into the procedures and the definitions of various terminology used in the regulation. The decision making process as to when a Medical Device Report (MDR) must be filed is the single most area where device firms fails to make rational or informed decisions.
Why should you Attend: Medical Device manufacturers are aware that if an end user reports an injury to them purported to be the result of a malfunction of their device, that they must report this incident with FDA.
What they fail to always take into consideration are the other incidents that also require a Medical Device Report 3500A be filed with FDA.
Some medical device firms fail to properly establish Medical Device Reporting procedures to capture all the requirements in 21 CFR 803.
Sufficient time will be provided for Q&A.
Areas Covered in the Session:
- What should be included in your Medical Device Reporting Procedures
- What is a Medical Device Report 3500A
- What is eSubmitter
- Definitions of Serious Injury
- When to report to FDA
- How to report to FDA
- What can happen when you fail to report
Who Will Benefit:
- All Medical Device manufacturers regardless of Class of Medical Device