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Titles
- Unique device identification: direct marking of devices : guidance for Industry and Food and Drug administration staff1
- Unique device identification: policy regarding compliance dates for class I and unclassified devices : immediately in effect guidance for industry and Food and Drug Administration staff1
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process": guidance for industry and Food and Drug Administration staff1
- Use of electronic health record data in clinical investigations1
- Use of public human genetic variant databases to support clinical validity for genetic and genomic-based in vitro diagnostics: guidance for stakeholders and Food and Drug Administration staff1
- Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and Food and Drug Administration staff1
- Use of serological tests to reduce the risk of transmission of Trypanosoma cruzi infection in blood and blood components1