Acts, Rules and Regulations

There are several statutory and regulatory provisions pertaining to the classification and assignment of biological products, drugs, devices, and combination products.  The following provides a listing of some of these provisions.

• 21 CFR Part 3 - the regulations pertaining to the assignment of products to FDA components for review of premarket applications
  • 21 CFR 3.4 – the regulation regarding how FDA designates the review of combination products.  Designation of lead FDA review center is based on the Primary Mode of Action (PMOA) of a product.  FDA issued a final rule on August 25, 2005 for the definition of PMOA.  Refer to 70 FR 49848 for more information.

• Statutory provision regarding classification of products and the roles and responsibilities of the Office of Combination Products can be found in section 563 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb-2]
• The Office of Combination Products was established on December 24, 2002 as required by SEC. 204 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).
• Definitions of biological product, drug, device and combination products
  • Biological product – section 351(a) of the Public Health Service Act [42 U.S.C. 262(i)] and 21 CFR 600.3(h)
  • Drug - section 201(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321(g)]
  • Device - section 201(h) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321(h)]
  • Combination product - section 503(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C 353 (g)] and 21 CFR Part 3.2(e)