Corrections and Removals - Understanding and Implementing the Final Guidance Document 2015

Topics

• The guidance document and its intention and use
• The provisions of the regulations that relate to devices with problems
• The four exemptions for reporting
• The regulations for correction & removal
• How FDA will classify the report as a recall
• The need to keep records when a change is not reportable
• You obligations to manage the recall

Who should Attend

Attendees from:

• Quality Assurance
• Professionals from device companies involved in production changes, design changes, medical device reporting, and field actions:
• Legal Counsel
• Regulatory Affairs
• Medical Device Reporting Specialists
• Complaints Specialists
• Risk Management Specialists
• Field Change Specialists