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performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA's new Draft Guidance, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated October 25, 2017.
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'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 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 the industry for further 510(k) changes in the future.
Webinar Takeaway
- 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
Speakers
John E. Lincoln,
Principal Consultant ,
J. E. Lincoln and Associates LLCJohn E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company, with over 33 years’ experience in U.S. FDA-regulated industries and 20 years as a full-time consultant. He 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 so+E6ftware validations, ISO 14971 product risk management files / reports, design control / design history files, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CGMP subjects. He is a graduate of UCLA.
Who Should Attend
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
