---
kind: "section"
citation: "21 C.F.R. § 884.5370"
title: "21"
number: "884.5370"
heading: "Software application for contraception."
url: "https://uscodex.org/cfr/21/884.5370"
---

# §884.5370. Software application for contraception.

- (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.

## Notes

### Amendments

[84 FR 7995, Mar. 6, 2019]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

### Source

Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.

### Amendments

[84 FR 7995, Mar. 6, 2019]