1. How to prepare a pre-request for designation (pre-RFD) Publication: [Silver Spring, Maryland] : Office of Combination Products, Office of the Commissioner, February 2018 Subject(s): Equipment and Supplies -- classificationDrugs, Investigational -- classificationInvestigational New Drug ApplicationPharmaceutical Preparations -- classificationHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. 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.
