1. Health document submission requirements for tobacco products: (revised) Publication: Silver Spring, MD : Center for Tobacco Products, October 2017 Subject(s): Documentation -- standardsTobacco Products -- standardsDrug ApprovalHealthTerminology as TopicTobacco Products -- adverse effectsTobacco Products -- toxicityHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.United States.
2. Referencing the definition of “device” in the Federal Food, Drug, and Cosmetic Act in guidance, regulatory documents, communications, and other public documents: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, November 14, 2022 Subject(s): Government RegulationMedical Device LegislationTerminology as TopicUnited StatesUnited States. Food and Drug AdministrationUnited States.