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Validity : 29th Nov'24 to 09th Dec'24
Device Changes, FDA Changes, and the 510(k)
- Current FDA Expectations
- Key requirements of the two Guidance Documents on Changes and the 510(k)
- Expected sources of information for evaluation and inclusion
- Approaches to the use of the FDA's two Guidance Documents
- Step-by-step analysis: Manufacturing, Labeling, Tech / Performance, and/or Materials Changes
- Change reporting "tipping point" -- with one change or cumulative
- Which of the three major 510(k) formats should be used
- How to complete, document and control as a 'living' document
Overview of the webinar
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 Guidances, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a [Software] Change to an Existing Device". It will discuss allowed alternatives to filing when in a “gray area”, and 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. This applies to companies in the Medical Device and combination products fields.
Who should attend?
- Senior management in Devices, Combination Products
- QA / RA
- Medical products development and testing teams
- R&D
- Engineering
- Production
- Operations
- Marketing
- Consultants; others tasked with medical product development, manufacturing, logistics and V&V responsibilities
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", onOctober 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.
Faculty - Mr.John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 27 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, 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 ptublished 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.