Compliance Glossary

Public health activities include the reporting of disease or injury; conducting public health surveillance; reporting vital events (e.g., births or deaths); reporting child abuse and neglect;  investigations or interventions; and monitoring adverse outcomes related to drugs, food (including dietary supplements), biological products, and medical devices. Covered entities may report adverse activities related to public agencies or events related to FDA-regulated products as well as private entities that are subject to FDA jurisdiction.