FDA CDRH “Guidance for Industry: Frequently Asked Questions on the new 510(k) Paradigm” issued October 22, 1998. This document answers questions regarding use of special and abbreviated 510(k)s for medical devices and provides examples of documentation required including requirements and an example for the design control summary as well as several references to risk analysis. This document supplements the Guidance “The New 510(k) Paradigm: Alternate Approachesto Demonstrating Substantial Equivalence in Premarket Notifications”.