Online Webinar 2019 - 3 hrs Virtual Seminar Latest FDA thinking on deciding when to Submit a 510(k) for a Change to an Existing Device - FDA's Final Guidance

Overview
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 New Guidance Documents in October 2017, "Deciding When to Submit a 510(k) for a Change to an Existing Device", 1) on the device itself, and 2) on device software. These documents provide companies tools to perform meaningful, results driven 510(k) / change analysis activities. They replace the FDA’s previous Memorandum K 97-1 on the same subject. This is part of a growing push by the Agency to strengthen the 510(k) process. The addition of simple tools will assist companies in implementing formal, documented, repeatable methods with defensible rationale for their decisions on when one or several changes may require a new 510(k) submission.
Session Highlights
Key elements of U.S. FDA’s new Guidance on Deciding When to Submit a 510(k) for a Change to an Existing Device, released October 25, 2017;
Key elements of the U.S. FDA’s new Guidance on Deciding When to Submit a 510(k) for a Software Change to an Existing Device, also released October 25, 2017.
Impact on now replaced U.S. FDA 510(k) Memorandum K97-1 on Deciding When to Submit a 510(k) for a Change to an Existing Device, in effect since January 10, 1997.
How might these guidance documents affect current device change decisions and 510(k) submissions.
What approaches can companies use at present, and the Agency’s expectations.
Learning Objectives
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 two new Guidance documents on 510(k) Device and Software changes. It will discuss how companies can best document their decisions -- whether or not a new 510(k) filing is 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. This applies to companies in the medical device and combination products fields.
Who should attend this event
Senior management in Devices and Combination products
QA/RA
R&D
Engineering
Software engineers
Marketing
Consultants
All others tasked with device change analysis and device submissions to the U.S. FDA
PRESENTER
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 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. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA