CFR section
21 CFR 812.5(a): Labeling of investigational devices
PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS · Subpart A-General Provisions
Key facts
| Citation | 21 CFR 812.5(a) |
|---|---|
| Section | Labeling of investigational devices |
| Part | PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS |
| Subpart | Subpart A-General Provisions |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, General |
| Regulation text (excerpt) | (a) Contents. An investigational device or its immediate package shall bear a label with the following information: the name and place of business of the manufacturer, packer, or distributor (in accordance with § 801.1), the quantity of contents, if appropriate, and the following statement: “CAUTION-Investigational device. Limited by Federal (or United States) law to investigational use.” The label or other labeling shall describe all relevant contraindications, hazards, adverse effects… |
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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.