Requirements for Manufacturers and Producers

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. In Vitro Diagnostic Products for Human Use
  7. Requirements for Manufacturers and Producers

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Section
809.20

General requirements for manufacturers and producers of in vitro diagnostic products.

Section
809.30

Restrictions on the sale, distribution and use of analyte specific reagents.

Section
809.40

Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing.