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 In this section:

                Guidance & Regulatory Information

Guidance & Regulatory Information

                        Acts, Rules and Regulations
          Combination Products Guidance Documents
          Intercenter Consultative/ Collaborative Review Process
          Postmarketing Safety Reporting for Combination Products
          Genus v. FDA D.C. Circuit Court Decision and transition from drugs to devices Home
          Combination Products
          Guidance & Regulatory Information
          Acts, Rules and RegulationsGuidance & Regulatory Information Acts, Rules and Regulations
  
  	
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    PrintThere 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, 201621 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 Act21 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 42 U.S.C. 262(i)and 21 CFR 600.3(h) - Biological product – section 351(a) of the Public Health Service Act21 U.S.C. 321(g) - Drug - section 201(g) of the Federal Food, Drug, and Cosmetic Act21 U.S.C. 321(h) - Device - section 201(h) of the Federal Food, Drug, and Cosmetic Act21 U.S.C 353 (g) - Combination product - section 503(g) of the Federal Food, Drug, and Cosmetic Act**Regulations**21 CFR Part 4 – the regulations pertaining to current good manufacturing practices and postmarket safety reporting requirements for combination products Final rule on postmarketing safety requirements for combination products, December 20, 2016Final rule on current good manufacturing practice requirements for combination products, January 22, 201321 CFR Part 3 - the regulations pertaining to the classification of medical products as drugs, devices, biological products, or combination products and their assignment to FDA components for premarket review and regulation 21 CFR 3.2(e) – Definition of a combination product21 CFR 3.7 – requirements for RFD submissionsFinal rule to define “mode of action” (MOA) and “primary mode of action” (PMOA), August 25, 2005Proposed rule to amend regulations concerning the classification of products as biological products, devices, drugs, or combination products, and their assignment to Agency components for premarket review and regulation. May 15, 2018

                                                                                  Content current as of:
      05/25/2018Guidance & Regulatory Information

          
                        Acts, Rules and Regulations
          Combination Products Guidance Documents
          Intercenter Consultative/ Collaborative Review Process
          Postmarketing Safety Reporting for Combination Products
          Genus v. FDA D.C. Circuit Court Decision and transition from drugs to devices
 
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