FDA Approval Process for Medical Devices

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States. Participants will gain an understanding of the underlying legal and regulatory requirements and the “general controls” applicable to all devices, including device classification, establishment registration and device listing. With the underlying framework in mind, the approval and clearance processes for new and modified devices will be presented, including 510(k), IDE, PMA, HDE and De Novo applications. Application contents, review processes, timelines, and key guidance documents will be discussed for each major type of submission. Participants will also learn about the “pre-submission” process, which FDA strongly recommends prior to the initial submission of novel devices to help ensure a successful submission process. Finally, some “hot topics” will be presented. Depending on the interest of the participants, these may include new FDA requirements and policies involving Unique Device Identifier, regulation of device software, and how to distinguish device “enhancements” from being considered a recall.

Hot topics

• 21st Century cures legislation
• MDUFA IV changes
• Modifications to 510(k) Cleared Devices

Upon completion of this seminar, participants will:

• Understand the overall FDA medical device regulatory process
• Know what is required for 510(k), IDE, PMA, HDE and De Novo applications
• Understand how FDA processes premarket submissions
• Identify key guidance documents to help ensure a successful process
• Determine when pre-submission interaction with FDA is recommended
• Be aware of “hot topics” and areas of change