FDA Regulation of Medical Devices : Rules, Expectations and Needed Submissions

Overview:

This 60-minute Medical Device webcast is focused on the requirements of the US FDA Premarket Notification (510(k) and Premarket Approval (PMA) processes.

Designed to provide an understanding of the FDA expectations for information to be in place and submitted for medical devices requiring either a 510(k) submission or a premarket application (PMA), and clarify when each type of submission is appropriate, this webcast will be useful for everyone involved in developing and bringing to market a medical device, whether in management, production, quality, regulatory affairs or marketing. The Premarket Notification or 510(k) submission process is the preferred method for obtaining marketing clearance in the U.S. This webinar will introduce the basic concepts, clarify when the 510(k) process can be used, and describe the best practices of the 510(k) submission process.

This presentation will discuss the different types of 510(k) submission-the standard, special and abbreviated 510(k)s-and explain when each is appropriate. We also will review methods for finding predicates, using guidance documents and interacting with the agency. We also will explain the Premarket Approval (PMA) process, and when and how it is to be used. In addition, we will present other methods for discussing matters with the FDA, including the request for information (513g) submissions and pre-IDE meeting approaches.

Why should you Attend:Obtaining clearance from the US FDA is necessary to market a device in the United States, 40% of the global market. In order to market a medical device in the U.S., manufacturers, depending on their device, must go through different evaluation processes by the U. S. FDA: Class 1 - exempt; Class II - Premarket Notification, 510(k); or Class III - Premarket Approval (PMA), a much more involved, costly and time-consuming process. How to determine the Class of the device, knowing what kind of submission to make to the FDA, and what the submission should include, can be very difficult to understand. What indications to claim, what predicates to use, and when to report changes to the device can also be major challenges to prompt submissions and clearances. This webinar will provide an understanding of these critical decisions and processes, and will clarify what is required and expected for different types of devices.

Areas Covered in the Session:

• Overview of the US Medical Device classification scheme.
• Exempt, 510(k), and PMA device categories.
• U.S. FDA Class I, II, and III products.
• How to determine proper classification and Product Codes for your device.
• Types of 510(k) submissions and when to use each.
• The importance of the "Intended Use" statement.
• What is a "predicate" product in the 510(k) process?
• How to locate and choose predicate devices.
• FDA Guidance documents and testing requirements.
• What changes to the 510(k) process have already been implemented?
• What is contained in a 510(k) submission package?
• What to do if you make a change to your device.
• When to submit a 510(k) for a new or modified product.
• How to know whether clinical data is required.
• The Premarket Approval (PMA) process and submissions
• What is contained in the Premarket Approval (PMA) submission package
• What to do if clinical data are required for your 510(k) or PMA

• Senior and mid-level Management
• Medical Device Manufacturing and Executives
• Regulatory Affairs and Compliance Professionals
• Professionals involved with premarket notification to the FDA
• R&D Personnel involved in approving the design of medical devices
• New Product Project Leaders / Team Members
• Quality Assurance Professionals
• QA/QC Managers and Directors
• Quality Systems Personnel
• Research & Development
• Process Development staff
• R&D and Engineering staff
• Production Managers
• Sales Personnel involved in approving the marketing of medical devices