1. Requesting FDA feedback on combination products: guidance for industry and FDA staff Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, December 2020 Subject(s): Biological ProductsFormative FeedbackLegislation, DrugMedical Device LegislationUnited StatesUnited States. Department of Health and Human ServicesUnited States. Food and Drug Administration
2. Requests for feedback and meetings for medical device submissions: the Q-Submission Program : guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, January 6, 2021 Subject(s): Device ApprovalFormative FeedbackUnited StatesUnited States. Department of Health and Human ServicesUnited States. Food and Drug Administration