Class III summary

FDA expects the summary to be comprehensive and to cite its sources. A thin summary weakens the 510(k), because it suggests the submitter has not looked at what is known about the device type.

Class III summary means a summary of the types of safety and effectiveness problems associated with the type of device being compared and a citation to the information upon which the summary is based. The summary must be comprehensive and describe the problems to which the type of device is susceptible and the causes of such problems. (s) United States agent means a person residing or maintaining a place of business in the United States whom a foreign establishment designates as its agent. This definition excludes mailboxes, answering machines or services, or other places where an individual acting as the foreign establishment's agent is not physically present.

21 CFR, 807.3