Strategies for Preparing a Successful 510(k) Premarket Notification for FDA Submission

Why Should You Attend:

The 510(k) submission is made to the FDA to demonstrate that a subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device).

FDA generally requires 510(k) notification for Class II devices. The 510(k) process is relatively quick and relatively inexpensive (FDA aims for a 3 month review process). However, in reality, the review process can take considerably longer, from 6 months to one year in some cases.

This 3-hr session will focus on the FDA’s premarket notification [510(k)] submission process. The presenter will explain in detail the components and format of a 510(k) Premarket Notification and discuss strategies for preparing and submitting a successful 510(k) submission. You will also learn what questions to expect from FDA in response to a pending 510(k).

Areas Covered in the Seminar:

• FDA regulations applicable to a 510(k) submission.
• Overview of the 510(k) program and recent changes in the 510(k) program.
• Identification of the 510(k) regulatory requirements.
• Discussion of the 510(k) submission requirements for medical devices and in vitro diagnostic devices.
• How to identify and select an appropriate Predicate Device.
• List of applicable FDA guidance documents and reference standards.
• Systematic methods to increase 510(k) submission quality.
• Formatting a 510(k) for submission; 510(k) contents for medical devices and in vitro diagnostic devices; and strategies for preparing successful 510(k) notification submissions.
• Responding a CDRH Responses to a pending 510(k).
• Instructor’s recommendations for success.