Deciding When to Submit a 510(k) for a Change to an Existing Device 2018 is a webinar that covers topics such as:
- 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?
Deciding When to Submit a 510(k) for a Change to an Existing Device 2018 is intended for:
- Quality Engineers
- Quality Managers
- Small Business Owners
- Regulatory Affairs
