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

This 90-minute webinar will explain FDA's 1997 guidance on 510(K) for device modifications and show how to integrate the evaluation into your design change program. The webinar uses numerous Warning Letters to illustrate the points, and helps you learn from others.

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