Device and Software Changes and The 510(k)
John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a
consulting company with over 35 years of experience in U.S. FDA-regulated
industries, 21 of which are independent consultants. 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). John has prior experience in the 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 periodically writes for the Journal of Validation Technology. John is a graduate of UCLA.
This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results-driven 510(k) / change analysis activities, based on the U.S. FDA has its current two recent “Final Guidance for Industry and FDA Staff”: “Deciding When to Submit a 510(k) for a Change to an Existing Device”; and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device“; both dated November 16, 2017. The webinar will discuss how companies can best navigate the decision process using these guidance documents, alternatives necessary to address the inevitable “gray” areas successfully, and then document their decision when 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 the industry for further 510(k) changes in the future. This applies to companies in the Medical Device and combination products fields.
The FDA had published its K97-1 Memorandum, draft guidance, and finally two recent final guidances to assist companies to a correct decision as to when a major device change or a series of lesser changes finally trigger the need to file a new 510(k).
- The important formal CGMP-compliant Change Control system and its documentation
- Key requirements of the two recent Final Guidance on Changes and the 510(k) and Safety and Efficacy
- Addressing the single triggering change, and the tipping point after a series of device changes (software and/or hardware)
- Expected sources of information for evaluation and inclusion
- Step-by-step analysis: Manufacturing, Labeling, Tech / Performance, and/or Materials Changes
- A risk-based phased approach, and the only FDA-acceptable meaning for “risk-based”
- 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
Course Level - Beginner to Intermediate
Who Should Attend
This webinar will provide valuable guidance to regulated companies in the development and implementation of formal, defined, documented methods for the analysis of product changes and when to file a new 510(k). Consideration of the U.S. FDA's current final guidance documents of device changes, and tools available / encouraged in the CGMPs, will provide tools to document such decisions.
- Design and Manufacturing Engineers
- Computer programmers and Testers
- Management and Supervisory Personnel
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 its current two recent “Final Guidance for Industry and FDA Staff”: “Deciding When to Submit a 510(k) for a Change to an Existing Device”; and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device“; both dated November 16, 2017, designed to strengthen the 510(k) process. These documents supersede “Deciding When to Submit a 510(k) for a Change to an Existing Device, dated January 10, 1997. These Guidances provide companies tools to perform meaningfully, results-driven 510(k) / change analysis activities, but still “gray” areas. How can companies utilize these tools, and successfully address the remaining “gray” areas? The addition of simple tools will assist companies in implementing formal, documented, repeatable methods with defensible rationale for their decisions on when a new 510(k) needs submission.