Overview: This presentation will review the Medical Device Reporting regulations and common violations leading to Warning Letter filings by FDA.
As part of the review, actual Warning Letter and FDA-483 citations of small and large medical device manufacturers will be explored for Medical Device Reporting issues. There is a great deal of concern at FDA over the quality of the information being reported and the timeliness. Some at FDA are concerned that manufacturers have not placed adequate attention to following these regulations, which they consider to be primary indicators of safety issues and therefore very important to the public health. FDA is working to improve reporting by manufacturers, but also is working to improve systems in FDA to evaluate the data being received. FDA is currently receiving reports in several different systems, but will be switching over to an electronic reporting system. The presentation will review FDAs improvements activities including the status of the electronic system and describe the upcoming requirements for manufacturer reporting.
Why should you attend: Medical device manufacturers continue to have problems with the MDR regulations and reporting of potential adverse events and possible device malfunctions. The regulation has been unchanged for several years, but FDA continues to find violations of these regulations. Both large and small manufacturers have been cited by FDA investigators as a result of directed and routine inspections. Findings include lack of procedures, not following company procedures, as well as not filing reports in a timely manner as required in the regulations. FDR considers violations of the Medical Device Reporting regulations to be serious and often issues Warning Letters to manufacturers for these violations.
Areas Covered in the Session: - Review the FDA`s Medical Device Reporting requirements.
- Review FDA 483 MDR Reporting issues
- Review Warning Letter Medical Device Reporting citations
- Establish common problems in MDR reporting
- What should MDR procedure contain?
- What actions should be taken by complaint personnel?
- Identify audit actions for medical device manufacturers
Who Will Benefit: - Regulatory Management
- Internal Auditors
- Quality System Managers
- Complaint system personnel
- Regulatory Associates
