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1761. Pediatric information for x-ray imaging device premarket notifications: guidance for industry and Food and Drug Administration staff

1762. 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

1763. 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

1764. Technical considerations for additive manufactured medical devices: guidance for industry and Food and Drug Administration staff

1765. Use of serological tests to reduce the risk of transmission of Trypanosoma cruzi infection in blood and blood components

1766. Software as a medical device (SAMD): clinical evaluation : guidance for industry and Food and Drug Administration staff

1768. Systemic antibacterial and antifungal drugs: susceptibility test interpretive criteria labeling for NDAs and ANDAs

1769. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system

1770. Best practices for communication between IND sponsors and FDA during drug development: guidance for industry and review staff : good review practice