regulator · United States
U.S. Food and Drug Administration
US federal regulator for drugs, biologics, medical devices, and food. Operates MedWatch for adverse-event reporting and clears or approves devices used in clinical practice.
Scope of authority
Drug, biologic, device, and food authorisation; post-market surveillance.
Complaint pathway
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters — https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters