CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

PART 809 IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE

Subpart A - General Provisions
   § 809.3 - Definitions.
   § 809.4 - Confidentiality of submitted information.

Subpart B - Labeling
   § 809.10 - Labeling for in vitro diagnostic products.
   § 809.11 - Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile.

Subpart C - Requirements for Manufacturers and Producers
   § 809.20 - General requirements for manufacturers and producers of in vitro diagnostic products.
   § 809.30 - Restrictions on the sale, distribution and use of analyte specific reagents.
   § 809.40 - Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing.

Authority: 21 U.S.C. 331, 351, 352, 355, 360b, 360c, 360d, 360h, 360i, 360j, 371, 372, 374, 381.