1. Classification of products as drugs and devices & additional product classification issues: final guidance : guidance for industry and FDA staff Publication: Silver Spring, MD : Office of Combination Products, Food and Drug Administration, September 2017 Subject(s): Biological Products -- classificationClassification -- methodsEquipment and Supplies -- classificationPharmaceutical Preparations -- classificationHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Evaluation of devices used with regenerative medicine advanced therapies Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, February 2019 Subject(s): Device ApprovalEquipment and Supplies -- classificationRegenerative Medicine -- classificationRegenerative Medicine -- instrumentationBiological Products -- classificationCell- and Tissue-Based Therapy -- classificationDrug ApprovalHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
