FDA's Two New Draft Guidance on Software and Device Changes and the 510(k)

Event Information
Product Format
Prerecorded Event
Presenter(s)
Conference Date
Tue, Sep 27, 2016
Length
90 Minutes
Product Description

Perform, Document Result-Driven and Meaningful 510(k) /Change Analysis Based on FDA's Current Guidance


If you’re to count the big issues in recent FDA studies, control of medical device changes and a current 510(k) will top the list, and guess what? Your company is held fully responsible when filing a new 510(k) warrantied. Often known as a difficult process, it is important that you put power of current risk management and effective change control as a major part of such analyses.

Two new draft guidance documents have been published by US FDAs current K-97-1 Memorandum which will be. “Deciding When to Submit a 510(k) for a Change to an Existing Device", on either the device itself, or the device software – both published on August 08, 2016. These are attempts so that company tools manage to perform meaningful and result-oriented 510(k) / change analysis activities. A part of the growing push by agencies to strengthen the 510(k) process, adding simple tools will assist your company to implement documented, formal, repeatable methods with defensive rationale when you need to decide on when a new 501(k) needs submission.

Join this webinar by expert speaker John E. Lincoln to get valuable assistance if you’re a regulated company looking forward to perform and document result-driven and meaningful 510(k) /change analysis activities that are based on the FDA's current Guidance on 510(k) Device Modifications:  Deciding When to Submit a 510(k) for a Change to an Existing Device, K97-1.

This session help you implement formal methods with documented and defensible rationale—which will prepare your organization for further 510(k) changes in the future, especially if your company is in the Medical Device and combination products fields.

This is a long awaited clarification of U.S. FDA’s Memo K97-1 for medical device manufacturers, with far-reaching effects in regulatory compliance regarding device changes and 510(k) “re-submissions”, as envisioned by the FDA. A must-know for all pharmaceutical and medical device industry professionals and organizations.

Session Highlights:

  • Key elements of U.S. FDA’s new Draft Guidance on deciding when to submit a 510(k) for a Change to an Existing Device, released August 08, 2016;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, released August 08, 2016.
  • Impact 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.
  • What the two new draft guidance tell us about current U.S. FDA expectations for such analysis and 510(k) submissions?
  • How you can best document decisions -- whether or not a new 510(k) filing is warranted?
  • 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?

Who Should Attend

  • QA/RA
  • Members of AQC, RAPS, AAMI, etc
  • CROs and Clinicals personnel
  • Medical personnel and Other healthcare professionals, staff and office personnel
  • Consultants
  • All others tasked with device change analysis and device submissions to the U.S. FDA

 Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

John E. Lincoln


John E. Lincoln is the 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 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...   More Info
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