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Subscribe NewsletterDesign Changes: When is a New 510(k) Required
Product Id
:
600077
Overview: This webinar will provide an overview of the FDA guidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device".
All of us in the medical device industry who are marketing devices under the 510(k) substantial equivalence regulations occasionally make changes or improvements to our devices. The question arises whenever a change is made as to whether or not the change being made is "Significant" enough to warrant the submission of a new 510(k). This decision is not always easy and the FDA provides many guidance documents to aid in determining the requirement.
An interpretation of the guidance and real life examples of when a new 510(k) is required will be discussed for each category of change. How does software play in this arena? Also, the path through the various flowcharts contained within the guidance documents lead into one of two directions: a New 510(k) or Documentation. This webinar will also review what is meant by "Documentation" or a "Letter to File" as it is also referred to and what the content of that documentation should be.
All of us in the medical device industry who are marketing devices under the 510(k) substantial equivalence regulations occasionally make changes or improvements to our devices. The question arises whenever a change is made as to whether or not the change being made is "Significant" enough to warrant the submission of a new 510(k). This decision is not always easy and the FDA provides many guidance documents to aid in determining the requirement.
An interpretation of the guidance and real life examples of when a new 510(k) is required will be discussed for each category of change. How does software play in this arena? Also, the path through the various flowcharts contained within the guidance documents lead into one of two directions: a New 510(k) or Documentation. This webinar will also review what is meant by "Documentation" or a "Letter to File" as it is also referred to and what the content of that documentation should be.
Areas Covered in the Session:
When is a New 510(k) Required for:
- Changes due to a Recall or Corrective Action
- Labeling Changes
- Technology or Performance Changes and
- Material Changes
Who Will Benefit:
- Design Engineers
- Quality Assurance Personnel
- Program Managers
- Manufacturing Engineers
- Regulatory Personnel
- Engineering Managers