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The U.S. FDA has its current K-97-1 Memorandum and has published two New Draft Guidance Documents, "Deciding When to Submit a 510(k) for a Change to an Existing Device", 1) on the device itself, and 2) on device software, both published on August 08, 2016. These 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 a new 510(k) needs submission.
Why Should You Attend:
This webinar will evaluate what the two new draft guidances tell us about current U.S. FDA expectations for analysis and resulting and 510(k) submissions. 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, device software / firmware development, and combination products fields.
Areas Covered in this Webinar:
Key elements of U.S. FDA’s new Draft Guidance on Deciding When to Submit a 510(k) for a Change to an Existing Device, released August 08, 2016
Key elements of the U.S. FDA’s new Draft Guidance on Deciding When to Submit a 510(k) for a Software Change to an Existing Device, also released August 08, 2016
Impact of proposed guidance documents on current 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 drafts affect current device change decisions and 510(k) submissions
What approaches can companies use at present, and the Agency’s expectations
Review of key points of K97-1 / current FDA expectations
Analysis of New Draft Guidance on Deciding When to Submit a 510(k) for a Change to an Existing Device, released August 08, 2016
Analysis of New Draft Guidance on Deciding When to Submit a 510(k) for a Software Change to an Existing Device, also released August 08, 2016
What all this tells companies today/ future
Who Will Benefit:
Senior Management in the Medical Device/ Software Industry
Software/ Firmware Engineers/ Programmers
Company Change Agents
Document Control Professionals
John 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, 19 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. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).
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