Medical Device Complaint Handling: MDR, Reports of Removals and Corrections
Overview:
This presentation will step through the FDA regulations relating to post-market product problems, and give examples of how FDA currently interprets these regulations. Following this presentation, you should be able to decide whether your customer complaint requires not only investigation, but reporting to FDA, and in what format the report should be made, and to which section of the Agency.
Why Should You Attend : Many device warning letters contain the complaint that the company has failed to adequately develop and maintain their system for dealing with product problems in the field, and that their response to the 483 pointing out this deficiency was inadequate, usually because it was not accompanied by revised documents, and evidence that personnel were adequately trained on the revised system, and evidence that the revised system was in fact working effectively. One major component of the description usually found lacking is the determination of when and how to notify FDA of the problem and how the company is dealing with it.
Areas Covered in the Session
- QSR Requirements for Complaint Handling 21 CFR 820.198
- Medical Device Reporting 21 CFR Part 803
- Reports of Corrections and Removals, 21 CFR Part 806
- HCT/P that are devices
- Combination Products
- Electronic Products
- When MDR, When electronic product reporting
- Repurchase, Repairs, Replacement
Who Will Benefit:
- QA specialist
- Complaint Coordinator
- Regulatory Specialist
- QA manager
- QA Trainer
- All above in Medical Device companies