FDA Approval for point of care medical device


We are developing a point-of-care medical device for pathogen detection such as COVID 19. This device is going to need FDA (Food and Drug Administration) approval for EUA (Emergency use authorization). We wrote the firmware on a silicon lab’s ARM-based process (Giant Gecko- EFM32GG) with FreeRTOS. The ARM process will communicate with an Android phone to receive instructions to control the hardware.

Does anyone have any knowledge of how the software (firmware with FreeRTOS) running on a medical device is examined? Will there be any issues with using FreeRTOS?

Thank You!


Can’t really say - devices are assessed at a system level. First, can the device cause harm? Presumably, yes, if there is a pathogen that is not detected. If so, then what is the implication of false negative or false positive result - what claims does the device make about its accuracy? If the device claims high accuracy then what impact can the kernel have on an incorrect detection? Etc. Answers to all those questions will lead you to what, if anything, you need to prove about the software. If you need something that is already certified to 510K then you may benefit from SafeRTOS with a certification pack.