Live Webinar FDA's Two New Guidance Documents on Software and Device Changes and the 510(k)

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Hear By John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries"

Control of medical device changes and a current 510(k) are big issues in recent FDA studies

Description

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 attempt to 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 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.    

Why should you attend

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.

Areas Covered

•      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.

Who will Benefit

•      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

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

John E Lincoln

Principal, J. E. Lincoln and Associates LLC

John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant. Mr. Lincoln 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 / CGMP audits and 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, he 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 is a graduate of UCLA.

Back to Top