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Webinar On - Medical Device Changes and the 510(k)

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Webinar On - Medical Device Changes and the 510(k)



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 The U.S. FDA has its current K-97-1 Memorandum (they recently pulled their proposed new draft Guidance Document, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device").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.

Areas Covered in the Session :

This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA's current Guidance on 510(k) Device Modifications. This session will cover:

  • 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



Webinar On - Medical Device Changes and the 510(k)

Source: Press Release



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