Docket Management
Docket: 02N-0534 - Medical Device User Fee and Modernization Act of 2002
Comment Number: EC -5

Accepted - Volume 1

Comment Record
Commentor Mr. Kelvyn Cullimore Date/Time 2003-02-18 17:50:58
Organization Dynatronics Corporation
Category Company

Comments for FDA General
Questions
1. General Comments Dynatronics is a small device manufacturer. The imposition of fees associated with 510(k) submissions could be a significant added cost for us unless reasonable and liberal bundling policies are implemented. A liberal policy on bundling of products under a single 510(k) submission will conserve resources of the Agency, expedite review times and minimize the financial impact on small device manufacturers. We recognize that guidelines must be established for such bundling. We would suggest the following for your consideration: 1) If the allowed claims are essentially the same for all products being bundled, then they should be eligible for bundling. 2) If the products reference the same CFR code they should be eligible for bundling. 3) Often it is the features of a particular product that help distinguish it from other products in the same family by the same manufacturer. Yet, those distinguishing features have no bearing on the basic function or allowed claims of the device. Therefore, devices that are simply subsets of another device in the same family of products by the same manufacturer should be eligible for bundling. These three guidelines are simple and straight forward. In our case, we will be introducing a new line of combination electrotherapy and therapeutic ultrasound devices in the very near future. There are five different devices each incorporating different features, but all being labeled with similar claims. In this particular example, there is one parent device that incorporates all features. The other four devices include some embodiment of the features in the parent device, but do not make any additional claims than are sought for the original parent device. If a separate 510(k) were required for each device it would result in simply taking the original parent 510(k) and editing out the features that do not apply for each device in the family. This seems a superfluous exercise and a waste of Agency and corporate resources. We would hope that FDA will not utilize MDUFMA as simply a fund raising instrument by requiring unneccessary 510(k) applications, but will instead realize the efficiency in bundling as liberally as possible in order to better utilize the resources available for 510(k) reviews.




EC -5