As you know, FDA check issue that is SWETYNTOOTH for all BLE Solutions to apply for medical solutions
So, My customer requested that is checking free from SWETYNTOOTH issue for Nordic nRF52840(SDK 15.2)
Because Customer solution is designed for Medical equipment
PLS let me know the above issue for nRF52840
|
Manufacturer |
Nordic |
|
Soc model |
nRF52840 |
|
SDK VER. |
SDK 15.2 |
|
BLE Ver |
4.2 |
PLS Ref Below reply from FDA
You indicated the use of Bluetooth Low Energy (BLE) communications with device. Cybersecurity researchers identified several system-on-a-chip (SoC) manufacturers which incorporate Software Development Kits (SDKs) for their Bluetooth communications which contain the Sweyn Tooth family of vulnerabilities. Detailed descriptions of the vulnerabilities and Proof-of-Concept code is available online from the research team's website. On March 3, 2020, FDA released a Safety Communication on these vulnerabilities. Based on the vulnerabilities and the description of the BLE communication in your system, we are unable to determine the possible impact to safety and effectiveness of these vulnerabilities to your system.
- Please provide the SoC manufacturer, SoC model, SDK version, and BLE version used in your system.
- Evaluate if your system is susceptible to the vulnerabilities.