1. Procedures for handling post-approval studies imposed by premarket approval application order: guidance for industry and Food and Drug Administration staff Publication: [Silver Spring, MD] : Center for Devices and Radiological Health, October 7, 2022 Subject(s): Clinical Studies as TopicDevice ApprovalGovernment RegulationUnited StatesUnited States. Food and Drug Administration
2. Patient engagement in the design and conduct of medical device clinical studies: guidance for industry, Food and Drug Administration staff, and other stakeholders Publication: Silver Spring, MD : Center for Devices and Radiological Health, January 26, 2022 Subject(s): Clinical Studies as TopicDevice ApprovalPatient ParticipationUnited StatesUnited States. Department of Health and Human ServicesUnited States. Food and Drug Administration
