Modifications to a Cleared Device - FDA's 510(k) Guidance

In January 1977, the FDA issued a guidance document to help device manufacturers understand when changes require a new 510(k). In 2011, FDA issued a draft guidance, that included a number of new proposals, with the intention of replacing the 1997 version. But, a new law, signed by the President on July 9, 2012, instructs the FDA to take a new direction and leaves the 1997 guidance in place.

Now is the time to review the 1997 guidance and make sure that your quality management system implements it. This webinar will help you identify the kinds of changes to consider, understand the regulation, and apply the guidance document.

The most important aspect of the webinar, however, is the approach to integrate the change control program across all the regulatory requirements. For example, do your complaint investigations lead to corrective actions, updates to your risk management file, product changes, and evaluation for 510(k) change? In the webinar, you learn how to make these links. You will also learn how to evaluate changes using the methods in the guidance, make the decision, and create adequate records.

At the end of the webinar, you will be able to implement a robust system that incorporates all the elements of product change control.

Why Should You Attend:

Your Quality Management System (QMS) should be able to address these questions quickly and easily. If not, then your team needs to attend this webinar!

• Your supplier made a change in an important part you purchase from them. Can your QMS link purchasing control to design changes to significant change evaluation?
• You decide to purchase an important part from a new supplier. Do you know the role that purchasing data plays in the 510(k) evaluation process?
• Your complaint analysis provides new information to update your ISO 14971:2007 risk management file. You realize that risk reduction requires a new contraindication. Can you change the labeling? Do you need a new 510(k)? Do you have to stop shipping the device until you receive a new clearance?
• Your complaint analysis suggests that you should change the expiration date on your device. Will you need a new 510(k) because of a shorter period?

Areas Covered in the Webinar:

• The status of the 510(k) guidance
  • What the new law requires
  • When FDA might be allowed to propose new guidance
  • When FDA might be allowed to implement new guidance
  • When FDA is allowed to change the regulation on 510(k) change submission
• A description of guidance document
  • Understand the flow charts and their structure
  • Evaluation of the questions and why they are important
  • Making the guidance into a record
• Understanding design change
  • Why FDA considers a design change and a production/process change are the same
  • Documenting the 510(k) evaluation in the design history file (DHF)
  • Identify sources and flows of potential design changes
• Implementation Recommendations
  • Integrating requirements
  • Updating procedures, work instructions, etc.
  • Warning Letters – Learning from others

Who will Benefit:

This webinar is for people involved in product change from recognition of a potential change to implementing the change to notifying FDA when required.

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

• Quality Managers
• Quality Professionals
• Production Managers
• Production Supervisors
• Manufacturing Engineers
• Production Engineers
• Design Engineers
• Risk Managers
• CA & PA Analyst
• Complaint Analysts
• Marketing
• Senior Management
• Suppliers to Medical Device Companies

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:

When you make a change to a cleared device, some regulations come into play. They include all the elements of design change control, 820.30(i), including verification, validation, review, risk management, and the design history file. Because the evaluation of a significant change or modification in design, components, method of manufacture, or intended use is in Part 807, many companies miss it as part of design change.

Section 807.81 contains the requirements and the guidance document tells the manufacturer how to implement it. The guidance has flow charts that lead you through the analysis process by using decision points based on questions in the guidance. Generally, the flow chants will lead you to one of two decisions: document the analysis or file a new 510(k).
The specifications, performance, size, or composition of the device to an extent greater than the specified limits

• Do you know the plan for the FDA's guidance document on 510(k) changes?
• Do you know how to evaluate changes to a cleared device to determine if you need a new 510(k)?
• Have you integrated this analysis into your design change and production and process change procedures?
• Do you know what records to maintain?

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