(a) Identification. A software application for contraception is a device that provides user-specific fertility information for preventing a pregnancy. This device includes an algorithm that performs analysis of patient-specific data (e.g., temperature, menstrual cycle dates) to distinguish between fertile and non-fertile days, then provides patient-specific recommendations related to contraception.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must demonstrate the contraceptive effectiveness of the software in the intended use population.

(2) Human factors performance evaluation must be provided to demonstrate that the intended users can self-identify that they are in the intended use population and can correctly use the application, based solely on reading the directions for use for contraception.

(3) Software verification, validation, and hazard analysis must be performed. Documentation must include the following:

(i) A cybersecurity vulnerability and management process to assure software functionality; and

(ii) A description of the technical parameters of the software, including the algorithm used to determine fertility status and alerts for user inputs outside of expected ranges.

(4) Labeling must include:

(i) The following warnings and precautions:

(A) A statement that no contraceptive method is 100% effective.

(B) A statement that another form of contraception (or abstinence) must be used on days specified by the application.

(C) Statements of any factors that may affect the accuracy of the contraceptive information.

(D) A warning that the application cannot protect against sexually transmitted infections.

(ii) Hardware platform and operating system requirements.

(iii) Instructions identifying and explaining how to use the software application, including required user inputs and how to interpret the application outputs.

(iv) A summary of the clinical validation study and results, including effectiveness of the application as a stand-alone contraceptive and how this effectiveness compares to other forms of legally marketed contraceptives.

[84 FR 7995, Mar. 6, 2019]