IGMPI India

The USFDA, has released two extensive draft guidance that would help the medical device manufacturers in developing blood glucose measuring devices. These drafts separately focus on devices for home use and those for professional use. FDA is now in favor of ascertaining the need to have unique features and device design requirements based on the user settings.

According to the regulators, there is difference in the understanding of a layperson and that of a trained professional from a medical background. While a trained professional can perform testing, understand test limitations and use appropriate measures, a layperson may not be able to appropriately use a technical device or interpret the data. Considering this, two separate drafts have been released, one focusing on the consumer use device and the other for professional use device.

The consumer use device guidance is named Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use. FDA recommends single use device to prevent the risk of transmission of disease through blood and should be cleaned and disinfected when required to share. The second guidance, which is named Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use, is meant for professional use and has details and cleaning requirements according to the purpose of use. The full guidance may be viewed Click Here and Click Here