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US FDA Guidance Documents: Device Changes and the 510(k)

Duration : 90 Minutes

John E. Lincoln,

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 38 years experience in U.S. FDA-regulated industries, 24 as an independent consultant. John has worked with companies from start-up to Fortune 100, world wide.  He specializes in quality assuranc Read more


This webinar will discuss both US FDA Guidance Documents: “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. It will examine the broad range of issues to be considered by a company when reviewing 1) a series of minor changes or 2) one major change to an existing product having an existing 510(k), for the need for a new 510(k). Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do to "toughen" the 510(k) process.  A review of recent information from the Agency, as well as other goals of the Agency that have already been translated into action in the past years will provide direction in areas of concern and what to expect in the future. This will assist documenting the 510(k) submission (or 'not') rationale.

Course Objectives:

The FDA expects companies to perform meaningful, results driven 510(k) / change analysis activities.  The company is held fully responsible for deciding when a new 510(k) filing is warranted. The old K97-1 Memorandum was replaced by two Guidance Documents, one on devices and one on device software changes:  “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  Growing high-profile field problems indicate that change control and it’s effect on regulatory review activities are not yet fully utilizing the power of current risk management tools, which must be a part of such an analysis .  A growing push by the Agency to strengthen the 510(k) process, and review existing devices with above normal adverse events are additional results. The required documented change  review actions are not rocket-science, but require the implementation of formal methods with documented, and defensible, rationale.

Why Should You Attend:

Every change to a medical device must be evaluated by the company as to (i) it’s individual effect on the previously FDA-cleared 510(k), regarding safety and effectiveness, and (ii) the latest changet and all previous changes cumulative effects on the past FDA-cleared 510(k), as to the need to file a new 510(k).  U.S. FDA's two guidance documents (and the old K-97 memo) on device and software changes, their flowcharts and questions as to when to file a new 510(k), wlil be discussed.

Course Outline:

• FDA Device Clearance / Changes in Direction
• Capturing Changes
• Requirements for Product Changes and When to File a New 510(k)
• Manufacturing, Labeling, Tech/Performance and/or Materials Changes
• Tracking / Evaluating Changes and the "Tipping Point"
• Using FDA's Guidance "Decision Trees" Model / Matrix
• Documenting the process
• Resolving a "Wrong" Decision.

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Senior and Middle Management
• Validation
• Marketing
• Production
• QA/RA
• Supervisors
• R&D
• Manufacturing Engineering
• Software Engineering
• Operations
• Production

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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