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

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