Webinar Duration: 90 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)


When your firm finds a problem with one of the devices you already shipped, fix it for the customer. 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. You need to make sure you know the when to report and when a record is adequate.

Why should you attend: An FDA Inspection will check for Corrections and Removals during an inspection. Often Inspectors will check specific actions, since they will monitor your website and usually get a copy 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.

Participant 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 Session
– 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The draft guidance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:
– Quality Professionals
– Regulatory Professionals
– Risk Management Specialists
– Complaint Managers and Specialists
– Compliance Officers
– General/Corporate Counsel
– Regulatory/Legislative Affairs Professionals

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.