Scheduled On : Wednesday, February 12, 2014 at 1 PM EST | 10 AM PST
Duration : 60 MinutesREGISTER NOW !
Description :
This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k).
Consideration of the U.S . FDA's current K-97-1 Memo / guidance document on "510(k) Device Modifications"
Control of medical device changes and a current 510(k) are big issues in recent FDA studies. Companies are held fully responsible for deciding when a new 510(k) filing is warranted. Often this is a difficult decision process. Effective change control and the power of current risk management tools must be a major part of such an analysis. The U.S. FDA has its current K-97-1 Memorandum (they recently pulled their proposed new draft Guidance Document, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device"). K97-1 provides a tool to assist in device and new 510(k) / change analysis. The addition of such simple tools will assist companies in implementing formal, documented, repeatable methods with defensible rationale for their decisions on when changes trigger the need for a new 510(k) submission.
The K97-1 analysis is the preferable tool to work with a company's change control system to document the need to file, or the rationale for not submitting a 510(k). It is recommended as the preferred method for documentation of each change in a device during its lifecycle. Provides for a Step-by-step analysis: Manufacturing, Labeling, Tech / Performance, and/or Materials Changes. Consideration of which of the three major 510(k) formats should be used: Traditional, Special or Abbreviated.
Consideration of the U.S . FDA's current K-97-1 Memo / guidance document on "510(k) Device Modifications"
Control of medical device changes and a current 510(k) are big issues in recent FDA studies. Companies are held fully responsible for deciding when a new 510(k) filing is warranted. Often this is a difficult decision process. Effective change control and the power of current risk management tools must be a major part of such an analysis. The U.S. FDA has its current K-97-1 Memorandum (they recently pulled their proposed new draft Guidance Document, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device"). K97-1 provides a tool to assist in device and new 510(k) / change analysis. The addition of such simple tools will assist companies in implementing formal, documented, repeatable methods with defensible rationale for their decisions on when changes trigger the need for a new 510(k) submission.
The K97-1 analysis is the preferable tool to work with a company's change control system to document the need to file, or the rationale for not submitting a 510(k). It is recommended as the preferred method for documentation of each change in a device during its lifecycle. Provides for a Step-by-step analysis: Manufacturing, Labeling, Tech / Performance, and/or Materials Changes. Consideration of which of the three major 510(k) formats should be used: Traditional, Special or Abbreviated.
Areas Covered in the Session :
- Deciding When to Submit a 510(k) for a Change to an Existing Device, K97-1
- How to provide tools to document such decisions
- It will discuss how companies can best document their decisions -- whether or not a new 510(k) filing is warranted
- How to structure a decision matrix to document change decisions
- How to evaluate changes that could trigger the "Tipping Point"
- Who makes the decisions and how to defend them
- How to implement formal methods with documented, and defensible rationale
- Preparing for further 510(k) changes in the future
Who Will Benefit:
This webinar is a must for companies in the Medical Device and combination products fields. The employees who will benefit include:
- Research & Development
- Engineering Staff
- Quality Assurance
- Regulatory Affairs
- Lean & Six Sigma staff
- New Product Development
- Marketing
- Mid-level and Senior Management
- Project Leaders
- Consultants
Speaker Profile
