PR Notice 98-2: Liquid Chemical Sterilant Products

摘要

This notice advises applicants/registrants of antimicrobial pesticide products ofnew FIFRA provisions for liquid chemical sterilant products that are intended for use on critical or semi-critical devices. These products are no longer regulated as 'pesticides' by the Environmental Protection Agency (EPA), but as 'medical devices' under the regulatory authority of the Food and Drug Administration (FDA). The statutory change in authority was effective on August 3, 1996. This notice informs registrants of liquid chemical sterilant products how to ensure that their products remain in compliance with FIFRA requirements where FIFRA still applies, and how products no longer regulated under FIFRA will be treated by EPA.