Objectives of the Presentation
Why Should you Attend
- The relationship among Design Output, Design Transfer, and Production Control
- The reason why FDA could consider a Production Change as a Design Change
- The elements of the new UDI rule including the Device Identifier (DI)
- The triggers that create a new DI and to document your decision
- The requirement to evaluate change significance for 510(k) purposes
- Use of the 510(k) change guidance document to document your evaluation
- Changes to the Risk Management File as a result of a design change
- Implications for FDA Inspections
This webinar explains what you need to do to implement a fully compliant system.
FDA QSR has a section on design changes, 820.30(i), that provides the basic requirements. Unfortunately, it does not provide all of the information necessary to satisfy practical considerations and FDA Regulations.
The first consideration is production and process changes. The FDA's inspection document (QSIT) tells Investigators that these changes are also design changes. The webinar explains the reasoning and provides tools for you to make this evaluation.
The second consideration is Unique Device Identification (UDI). In this rule, you must create a new Device Identifier, and load the database, for every change that creates a new version or model. The definition is open to allow manufacturers the flexibility to make good decisions based on their products. Every design change requires evaluation and a documented decision.
The third consideration is a significant change that would require a new 510(k). In this rule, you evaluate device changes to determine if the change could significantly affect the safety or effectiveness of the device. These changes include design, material, chemical composition, energy source, or manufacturing process. Every design change requires evaluation and the decision recorded. The FDA has a guidance document, published in 1997, that provides tools to help make this decision.
The fourth consideration involves corrections and removals. You need to classify each change as either an enhancement or a fix to a violation. You must report most fixes, which FDA will classify as a recall. Some, however, are exempt so you need to add further classification.
The fifth consideration involves risk management. An ISO 14971:2007 implementation requires a Risk Management File. Every design change has the potential to revise the file. You need to evaluate any impact and update the hazard analysis, the risk, and the risk control measures.
Who can Benefit
People in the following roles can especially benefit from the knowledge in this webinar:
- Regulatory Managers
- Recall Coordinators
- Engineering Managers
- Design Engineers
- Quality Managers
- Quality Engineers
- Project Managers
- Risk Managers
- UDI Regulatory Contacts
- UDI Coordinators