21 CFR 880.2915 — Body Temperature Sensing Software
General Hospital (HO) · Part 880 Subpart C—General Hospital and Personal Use Monitoring Devices · § 880.2915
Identification
Body temperature sensing software is a software device used for the determination of human body temperature by means of analyzing input sensor data. The Body Temperature Software (BTS) App is a software-only mobile medical application intended for over-the-counter (OTC) use with compatible mobile computing platforms that includes a general purpose infrared sensor for the intermittent determination of human body temperature on people of all ages.
Classification Rationale
Class II (special controls). The device is classified under 21 CFR 880.2915.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QZA | Body Temperature Sensing Software | 2 | 2 | SaMD |
Special Controls
QZA — Body Temperature Sensing Software
In combination with the general controls of the FD&C Act. the body temperature sensing software is subject to the following special controls:
De Novo Order DEN230050
