CDRH activities affecting the marketing of laser products in the United States

Abstract

This tutorial paper provides a brief summary of the CDRH activities and philosophies that impact the marketing of laser products in the United States. The paper contains background and history followed by a listing of the more recently published guidance documents with brief descriptions of the policies that they contain. Although the guidance documents can freely be accessed from the Internet, this paper can serve as a useful navigational aid in locating the documents that are needed by the manufacturers.This tutorial paper provides a brief summary of the CDRH activities and philosophies that impact the marketing of laser products in the United States. The paper contains background and history followed by a listing of the more recently published guidance documents with brief descriptions of the policies that they contain. Although the guidance documents can freely be accessed from the Internet, this paper can serve as a useful navigational aid in locating the documents that are needed by the manufacturers.