This Technical Information Report (TIR) covers the selection and use of chemical sterilizing agents (except for ethylene oxide) that have been cleared for marketing by the Food and Drug Administration (FDA). Topics specifically addressed include the general safety and performance characteristics of chemical sterilants and high-level disinfectants; the basic types of chemical sterilants/high-level disinfectants and chemical sterilization techniques; the mechanisms by which manufacturers obtain FDA clearance for the marketing of their products; and questions that users should ask of manufacturers when choosing a product for use on a particular medical device. The TIR also provides general guidance on the use of chemical sterilants and high-level disinfectants, as well as a glossary, a bibliography, and informative annexes.