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  1. Guidance & Regulatory Information

Acts, Rules and Regulations

There are various statutory and regulatory provisions pertaining to the regulation of combination products and to the classification and assignment of biological products, drugs, devices, and combination products. The following are some of the provisions focused specifically on these topics.

Statutory provisions

  • 21st Century Cures Act, Section 3038. Combination Product Innovation, December 13, 2016
  • 21 USC 360bbb-2 - Statutory provisions pertaining to classification and assignment of medical products can be found in section 563 of the Federal Food, Drug, and Cosmetic Act
  • 21 USC 353(g) - Statutory provisions relating to the assignment of combination products to Agency components, to their premarket and postmarket regulation, and to associated responsibilities of Agency components including the Office of Combination Products can be found at section 503(g) of the Federal Food, Drug, and Cosmetic Act Statutory definitions



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