CFR section
21 CFR 809.10(c)(2)(ii): Labeling for in vitro diagnostic products
PART 809-IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE · Subpart B-Labeling
Key facts
| Citation | 21 CFR 809.10(c)(2)(ii) |
|---|---|
| Section | Labeling for in vitro diagnostic products |
| Part | PART 809-IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE |
| Subpart | Subpart B-Labeling |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, General |
| Regulation text (excerpt) | (ii) For a product being shipped or delivered for product testing prior to full commercial marketing (for example, for use on specimens derived from humans to compare the usefulness of the product with other products or procedures which are in current use or recognized as useful), all labeling bears the statement, prominently placed: “For Investigational Use Only. The performance characteristics of this product have not been established.” |
At a glance
- 1–9 Inspections citing this section
- None Warning letters citing this section
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About CFR sections cited by the FDA
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.