Maker Pro
Maker Pro

Bluetooth pairing + FDA



Jan 1, 1970
I am using some Bluetooth modules and it is important that the devices
are paired uniquely. The product needs to meet all the regulatory
requirements for the FDA and I was told by a friend that they will not
allow pairing of devices based off a software key. My understanding
was that there had to be a hardware key (dongle, sdcard) or something
on the device to be sure there are not mistakes with pairing.

Do you guys have any ideas on this? How are medical device companies
doing this?

Also how many devices should I be able to connect up to the monitoring
device? Is each device on its own channel? How is the data read from
all these channels? Any information on this would be great.


- Dutchman