Overview: This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly.

Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory and financial health. Your goal is to get the 510(k) through the review process as quickly as possible. This presentation will also distinguish between the standard, special and abbreviated 510(k)s, and explain when each is appropriate. This course will describe the submission process and the contents required by the FDA for a successful submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures. Also described will be the type of activities a company can pursue while waiting for submission clearance.

Areas Covered in the Session:

• When to submit a 510(k) for a new or modified product
• Types of 510(k) submissions and when to use each
• What is the submission process
• What is contained in a 510(k) submission package
• How to know whether clinical data is required
• How is the submission package assembled
• User fees and 510(k) submissions
• How to interact with the FDA and the reviewer

Who Will Benefit: This webinar will provide valuable assistance to all medical device companies that prepare 510(k) submissions. The employees who will benefit include:

• Executive Management
• Regulatory Management
• Professionals involved with premarket notification to the FDA
• R&D personnel involved in approving the design of medical devices
• Sales personnel involved in approving the marketing of medical devices

Overview: The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.

The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes. What approaches are required for product changes; for process changes. How is the process risk-based? How to maximize the process against scarce resources. What are the different considerations for CE-marked product?

Areas Covered in the Session:

• U.S. FDA device clearance / approval
  
• FDA's and EU's emphasis
  
• Product changes and filing a new 510(k) – who's responsible
  
• Tracking and evaluating changes – the "tipping point"
  
• Is the process "risk based"?
  
• K-97-1 and the FDA's "Decision Tree"
  
• Documenting the process / rationale
  
• Resolving a "wrong decision"

Who Will Benefit:

• Senior Management, Project Leaders, Internal / External Consultants
  
• Regulatory Affairs
  
• Quality Systems Personnel / QAE
  
• R&D and Engineering Staff
  
• Personnel involved in Lean and Six Sigma Initiatives
  
• New product development, regulatory submissions, driving company-wide quality initiatives, under a risk-justified approach
  
• CAPA personnel desiring to minimize post-production / life cycle, root cause investigation, and other costly problems.

Overview: This webinar will discuss the new draft guidance document from the FDA: "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated July 27, 2011. 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, including last summer's Working Group findings on the 510(k), Vol. I, as well as other goals of the Agency that have already been translated into action in the past year will provide direction in areas of concern and what to expect in the future. This will be performed by a review of FDA-stated areas of required review and a suggested matrix format. Anticipation and addressing such on-going product modifications / changes proactively will further prove a company is "in control", and assist documenting the 510(k) submission (or 'not') rationale.

Why should you attend: 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. Now a new draft guidance document from the FDA is designed to add more consistency to this process: "510(k) Device Modifications:  Deciding When to Submit a 510(k) for a Change to an Existing Device", dated July 27, 2011. In addition, 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 in the U.S. and take a renewed look at "grandfathered" product by the Agency is another result. Current methods are claimed to not be providing the product safety or efficacy seemingly promised. For most companies, the recommended fixes are not rocket-science, but require the implementation of formal methods with documented and defensible rationale.

Areas Covered in the Session:

• FDA Device Clearance / Changes in Direction
  
• The New Draft Guidance on Product Changes and Filing a New 510(k)
  
• The New Guidance on Manufacturing, Labeling, Tech/Performance and/or+B41 Materials Changes
  
• Tracking / Evaluating Changes and the "Tipping Point"
  
• FDA's K97-1 and "Decision Tree" Model / Matrix
  
• Resolving a "Wrong" Decision

Who Will Benefit:

• Senior management in Devices and Combo Products
  
• QA
  
• RA
  
• R&D
  
• Engineering
  
• Production
  
• Operations
  
• Consultants