Medical Device Changes and the 510(k)

Scheduled On : Wednesday, February 12, 2014 at 1 PM EST | 10 AM PST

Duration : 60 Minutes

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 The U.S. FDA has its current K-97-1 Memorandum (they recently pulled their proposed new draft Guidance Document, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device").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

Speaker Profile

John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.