Overview
This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S . FDA's two current guidance documents, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a [Software} Change to an Existing Device", will provide tools to document such decisions. These analysis must be done for 1) each change, and 2) all cumulative changes collectively, documented
Why Should Attend
The US FDA requires a formal review / document of all changes to determine if new issues of safety and efficacy have arisen resulting in the need to file a new 510(k).
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. A robust QMS and validation system can reduce the need for a new 510(k). 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.
Webinar Takeaway
- 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; and "grey" areas
- Change reporting "tipping point" -- with one change or cumulative
- Which of the three major 510(k) formats should be used
- The US FDA requires a formal review / document of all changes.
- The QSR/Validation: Possible Alternative to a New 510(k)
Who Will Benefit
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' two Guidance's, "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. This applies 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
Faculty 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 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. 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, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.