510(k) Update and Medical Device Changes

This webinar will provide valuable guidance to regulated companies on latest 510(k) updates and 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”

This seminar 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 Should Attend:

  • Research & Development Departments
  • Engineering Departments
  • Quality Assurance Departments
  • Regulatory Affairs Departments
  • Lean & Six Sigma staff
  • New Product Development
  • Marketing Departments
  • Mid-level and Senior Management
  • Project Leaders
  • Consultants

MD2582

John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.

He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.

JUST RELEASED
SEMINARS
&
WORKSHOPS
 



Untitled1


  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.