Deciding When to Submit a 510(k) for a Change to an Existing Device 2018

Topics

• Initial Risk Based Assessment
• Changes made with intent to affect device safety & effectiveness
• The role of validation & verification to determine whether a change could significantly affect device safety and effectiveness
• Use of Risk Management
• Appropriate comparative device and cumulative effect of changes
• Evaluating simultaneous changes to determine whether submission of a new 510(k) is required
• Is it a change in the indications for use statement?
• Substantial equivalence determination
• Is it a change in warnings or precautions?
• Does the change add or delete a contra-indication?
• Does the change alter the operating principle of the IVD?
• Could the change affect the directions for use of the device?
• Does a risk-based assessment of the changed device identify any new risks or significantly modified existing risks?
• Is the change identified in a device-specific final guidance or classification regulation?
• Do design verification and/or validation activities produce any unexpected issues of safety or effectiveness?

Who should Attend

• Quality Engineers
• Quality Managers
• Small Business Owners
• Regulatory Affairs