2-day In-person Seminar on “How to Prepare and Submit a Bullet Proof 510(k) and Latest FDA Proposed Changes to the Process” at Philadelphia

About this Conference

This Two-day course is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process. Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820.30 Design Controls. FDA provides guidance and this course will address key resources when making critical decisions.

For more than 30 years, the 510(k) process has consistently done a good job of protecting patients against unsafe products. The process is well designed to assess the safety and effectiveness of low and moderate risk medical devices whose risks are well understood from experience with similar devices. Various industry trade groups and associations are now somewhat concerned that the number and scope of FDA's recently proposed 510(k) changes could negatively impact the agency's mission to ensure American patients have timely access to safe and effective medical technologies.