---
kind: "section"
citation: "21 C.F.R. § 801.50"
title: "21"
number: "801.50"
heading: "Labeling requirements for stand-alone software."
url: "https://uscodex.org/cfr/21/801.50"
---

# §801.50. Labeling requirements for stand-alone software.

- (a) Stand-alone software that is not distributed in packaged form (e.g., when downloaded from a Web site) is deemed to meet the UDI labeling requirements of this subpart if it complies with the requirements of [paragraph (b)](#b) of this section and conveys the version number in its production identifier.
- (b) Regardless of whether it is or is not distributed in packaged form, stand-alone software regulated as a medical device must provide its unique device identifier through either or both of the following:
  - (1) An easily readable plain-text statement displayed whenever the software is started;
  - (2) An easily readable plain-text statement displayed through a menu command (e.g., an “About * * *” command).
- (c) Stand-alone software that is distributed in both packaged form and in a form that is not packaged (e.g., when downloaded from a Web site) may be identified with the same device identifier.

## Notes

### Amendments

[78 FR 58818, Sept. 24, 2013]

### Authority

Authority: 21 U.S.C. 321, 331-334, 351, 352, 360d, 360i, 360j, 371, 374.

### Source

Source: 41 FR 6896, Feb. 13, 1976, unless otherwise noted.

### Amendments

[78 FR 58818, Sept. 24, 2013]