Classification Names for Medical Devices and In vitro Diagnostic Products

摘要

The directory contains product names developed by the Food and Drug Administration (FDA) device classification panels and additional names established by FDA to support the premarket notification and other administrative processes. The directory updates and combines two separate editions of product code directories published in 1977. The previous editions were separate for medical devices and in vitro diagnostic products. Previous editions are obsolete. The directory and future editions will be published with the products combined. The product codes contained in the directory are to be used in any submissions to FDA which require a product code. Each product name is identified by a product code which consists of five digits (2-numeric, 3-alpha). The first two digits of the product code indicate the medical specialty under which the device was originally classified. The directory also contains the regulation citation to Title 21, Code of Federal Regulations and the class of the device. The directory is organized by 'keywords' in alphabetical order. If the device code does not reference a regulation citation, the device has not yet been classified and the product class indicated (I, II, or III) is a proposed class.