Comment from Substance Abuse Program Administrators Association

Summary: The Substance Abuse Program Administrators Association (SAPAA), a nonprofit trade association, supports the FDA's proposal to exempt certain Class II clinical toxicology devices from premarket notification requirements. They argue that the proposal will reduce regulatory barriers and improve flexibility for federally mandated drug testing programs, particularly for oral fluid testing. They also request that the final rule be broad and flexible enough to accommodate emerging drug trends and avoid creating new obstacles for analytes without existing predicate devices.