CFR section
21 CFR 809.10(a)(9): 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)(9) |
|---|---|
| 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) | (9) A lot or control number, identified as such, from which it is possible to determine the complete manufacturing history of the product. (i) If it is a multiple unit product, the lot or control number shall permit tracing the identity of the individual units. (ii) For an instrument, the lot or control number shall permit tracing the identity of all functional subassemblies. (iii) For multiple unit products which require the use of included units together as a system, all units should bear the… |
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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.