How much leeway is there in deciding on the populations from which human specimens are collected and under what conditions are data on simulated specimens (see the Glossary for definition) acceptable?
Studies should be performed in a representative sample of the intended use population (i.e., representation of both diseased and non-diseased cases, and controlling for subject demographics and morbidity factors that may affect the level of device performance). When a disease is rare or samples are needed specifically to challenge cut-off points, sponsors may use enriched samples, panels of credentialed samples (e.g., Center for Disease Control and Prevention (CDC) panels), and/or spiked or contrived samples. The acceptance of simulated specimens depends on how well they represent specimens from the intended-use population and whether their performance accurately reflects what the IVD device user can expect.
Related Questions
- How much leeway is there in deciding on the populations from which human specimens are collected and under what conditions are data on simulated specimens (see the Glossary for definition) acceptable?
- What are examples of research involving human specimens, cells, cell lines, or data that would not be considered human subjects research under HHS regulations at 45 CFR Part 46?
- How do communicable disease in human populations may be prevented or controlled?
