CFR section
21 CFR 801.50(a): Labeling requirements for stand-alone software
PART 801-LABELING · Subpart B-Labeling Requirements for Unique Device Identification
Key facts
| Citation | 21 CFR 801.50(a) |
|---|---|
| Section | Labeling requirements for stand-alone software |
| Part | PART 801-LABELING |
| Subpart | Subpart B-Labeling Requirements for Unique Device Identification |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | (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. |
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Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.