A Special 510(k) may be an appropriate submission for a design modification to a device that has already been cleared under the 510(k) process. Utilizing the design control requirements of the U.S. Quality System Regulation, it allows a manufacturer to declare conformance to the design controls without having to provide extensive data.
 
 
GEMAR can help you determine if your device qualifies for this type of submission by evaluating each modification against specific criteria to insure that the change does not affect either the intended use or alter the scientific technology of the device. Once this has been done, we can also assist in preparation of the documentation required in the submission.