1. Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act: guidance for industry and Food and Drug Administration staff Publication: [Silver Spring, MD] : Center for Devices and Radiological Health, October 7, 2022 Subject(s): Device Approval -- legislation & jurisprudenceGovernment RegulationProduct Surveillance, PostmarketingUnited StatesUnited States. Food and Drug Administration
2. Annual status report information and other submissions for postmarketing requirements and commitments: using forms FDA 3988 and FDA 3989 : guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, September 2023 Subject(s): Forms as TopicGovernment RegulationProduct Surveillance, PostmarketingUnited StatesUnited States.United States.