CFR section
21 CFR 809.10(a)(6): 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(a)(6) |
|---|---|
| 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 |
| Regulation text (excerpt) | (6) For a reagent, a means by which the user may be assured that the product meets appropriate standards of identity, strength, quality and purity at the time of use. This shall be provided, both for the product as provided and for any resultant reconstituted or mixed product, by including on the label one or more of the following: (i) An expiration date based upon the stated storage instructions. (ii) A statement of an observable indication of an alteration of the product, e.g., turbidity… |
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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.