NLM Digital Collections

Search

Search Constraints

Start Over You searched for: Subjects United States. Department of Health and Human Services. Remove constraint Subjects: United States. Department of Health and Human Services. Subjects United States. Food and Drug Administration. Remove constraint Subjects: United States. Food and Drug Administration. Languages English Remove constraint Languages: English Publication Year 2017 to 2019 Remove constraint Publication Year: <span class="from" data-blrl-begin="2017">2017</span> to <span class="to" data-blrl-end="2019">2019</span>

Search Results

101. Unique device identification: direct marking of devices : guidance for Industry and Food and Drug administration staff

102. General principles for evaluating the abuse deterrence of generic solid oral opioid drug products

103. Pediatric information for x-ray imaging device premarket notifications: guidance for industry and Food and Drug Administration staff

104. Nucleic acid testing (NAT) for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV): testing, product disposition, and donor deferral and reentry

105. FDA categorization of investigational device exemption (IDE) devices to assist the Centers for Medicare and Medicaid Services (CMS) with coverage decisions: guidance for sponsors, clinical investigators, industry, institutional review boards, and Food and Drug Administration staff

106. Technical considerations for additive manufactured medical devices: guidance for industry and Food and Drug Administration staff

107. Use of serological tests to reduce the risk of transmission of Trypanosoma cruzi infection in blood and blood components

108. Software as a medical device (SAMD): clinical evaluation : guidance for industry and Food and Drug Administration staff

110. Systemic antibacterial and antifungal drugs: susceptibility test interpretive criteria labeling for NDAs and ANDAs