Medical Device Change(s) and the 510(k)

Why Should You Attend:

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 published two Guidance Documents, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change [and Software Change] to an Existing Device", on October 25, 2017, which provide companies tools to perform meaningful, results driven 510(k) / change analysis activities. This is part of a growing push by the Agency to strengthen the 510(k) process. The addition of simple tools, decision trees and questions, will assist companies in implementing formal, documented, repeatable methods with defensible rationale for their decisions on when a new 510(k) submission is required.

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' stwo Guidances, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a [Software] Change to an Existing Device". It will discuss how companies can best document their decision when a new 510(k) filing is not warranted. It will assist in the implementation of formal methods with documented, and defensible rationale; which will also prepare industry for further 510(k) changes in the future.

Areas Covered in the Webinar:

• Current Requirements of the K 97-1 Memorandum, and FDA Expectations
• Expected sources of information for evaluation and inclusion
• Two approaches to the use of FDA's K97-1 Memo
• Change reporting "tipping point" -- with one change or cumulative
• Step-by-step analysis: Manufacturing, Labeling, Tech / Performance, and/or Materials Changes
• Which of the three major 510(k) formats should be used
• How to complete, document and control as a 'living' document

Who Will Benefit:

This webinar will benefit to companies in the medical device and combination products fields. The employees who will benefit include:

• Senior management
• Regulatory affairs
• Quality Assurance
• Production
• R&D and Engineering
• All personnel tasked with new and changed product development and documentation

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 37 years’ experience in U.S. FDA-regulated industries, 23 as an independent consultant. John has worked with companies from start-up to Fortune 100, worldwide. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, submissions, process / product / equipment including QMS and software validations, ISO 14971 product risk management and human factors files / reports, Design History Files, Technical documentation. He's held positions in Engineering, QA, QAE, RA, 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, written numerous chapters for books on validation, conducted workshops and webinars worldwide. John is a graduate of UCLA.

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