Device Corrections and Removals

Why Should You Attend:

When your firm finds a problem with a device you shipped and fixes it, do you report it to the FDA?

If you send a letter to a customer that says, “We found a problem, but, not to worry, we will fix it for you!”, you may have invoked the Corrections and Removals process. Under Part 806 of the FDA regulations, you must report this event to FDA. Under certain circumstances, you may not need to report, but you must keep a record of your decision.

An FDA Inspection will check for Corrections and Removals since it is part of QSIT. Often Inspectors will check specific actions, since they will monitor your website and have copies of letters you sent to customers. If you send a letter that notifies your customers of a problem, it will almost certainly get to a competitor who will send a copy to FDA. If you didn’t report to FDA, the Inspector will ask for your records documenting the reason not to report. This webinar will clarify your obligations for corrections and Removal under Part 806.

Learning Objectives:

Attendees will learn

• The requirements of Part 806 including the difference between reports and records
• The difference between a correction and a removal and how to report them
• The exceptions in Part 806 and how to apply them to make the reporting decision
• What an Inspector will look for in a QSIT inspection
• What to look for in an effective program and how to ensure your program makes the grade
• The results of Warning Letters and how you can avoid some of the same issues
• The relationship with design changes and the potential need to update a 510(k)

Areas Covered in the Seminar:

• The basic requirements of Part 806.
• When to report.
• Exemptions that you may apply.
  • Market withdrawal
  • Routine servicing
  • Stock recovery
  • Reporting under Part 803 – Medical Device Reports
  • Reporting under Part 1004 – Repurchase, Repairs, or Replacement of Electronic Products
• The requirements of a report and the timing.
• The requirements for records when you don't report.
• The expectations of a QSIT Inspection.
• Elements of a robust system.
• How to check your system for compliance.
• Recalls.
• Design changes and potential 510(k) submissions.
  • The current guidance
  • The draft guidance

Who Will Benefit:

This webinar is for people involved in complaints, risk management, customer communication, and regulatory affairs.

People in the following roles can especially benefit from the knowledge in this webinar:

• Quality Professionals
• Regulatory Professionals
• Risk Management Specialists
• Complaint Managers and Specialists
• Compliance Officers
• General/Corporate Counsel
• Regulatory/Legislative Affairs Professionals

Instructor Profile:

Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Topic Background:

Often, device manufacturers think of FDA’s QSR as the regulation they must follow. Unfortunately, device manufacturers often forget about other parts of the regulations. One of the most commonly missed items is Reports of Corrections and Removals under Part 806.

Part 806 requires you to report to FDA, but it also has some exemptions. Often device makers, who are aware of the requirement, find it confusing to determine when an exemption applies. In addition, if an exemption applies, the device maker must keep records of the decision not to report.

FDA Inspectors check for these requirements, since it is part of the Quality System Inspection Technique. Increasingly, FDA issues Warning Letters to firms that don’t comply.

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