CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR801.50]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 801 -- LABELING

Subpart B - Labeling Requirements for Unique Device Identification

Sec. 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) 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.

[78 FR 58818, Sept. 24, 2013]