FDA
Manufacturers in the USA are expected to compile and maintain documentation that demonstrates the analytical and clinical performance of their IVD devices. From analytical validation studies to regulatory submissions and post-market surveillance, navigating the clinical aspects of IVD development requires meticulous planning, execution and adherence to regulatory requirements.
Our team can support you in the following clinical areas.
- Analytical and clinical performance evaluation: The FDA expects manufacturers to demonstrate both the analytical and clinical performance of their IVD devices. This involves conducting studies to assess the accuracy, precision, sensitivity, specificity and various other performance-related characteristics of the device.
- Analytical validation studies: Manufacturers must conduct analytical validation studies to evaluate your device's performance under controlled laboratory conditions. These studies assess its ability to accurately and reliably measure analytes of interest.
- Clinical validation studies: Clinical validation studies are conducted to evaluate the device's performance in real-world clinical settings. These studies compare the device's results to those of a reference method or gold standard and assess its diagnostic accuracy, sensitivity, specificity and various other clinical performance characteristics.
- Post-market surveillance (PMS): Manufacturers must implement post-market surveillance programmes to monitor the performance of their IVD devices after they are placed on the market. This includes not only collecting and analysing data on device failures, adverse events and several other safety or performance issues but also taking appropriate corrective and preventive actions when required.
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