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

This 90-minute 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performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA's new Draft Guidance, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated October 25, 2017.

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Last Recorded Date: Jan-2023

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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
Instructor Profile:
John E Lincoln 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 36 years’ experience in U.S. FDA-regulated industries, 22 as a full-time 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 including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. 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. John is a graduate of UCLA.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

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