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                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
          Intercenter Consultative/ Collaborative Review ProcessGuidance & Regulatory Information Intercenter Consultative/ Collaborative Review Process
  
  	
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    PrintOn July 31, 2002, FDA issued an internal document (SMG 4101) to provide the policies and procedures for FDA staff to follow when requesting, receiving, handling, processing, and tracking formal consultative and collaborative reviews of combination products, devices, drugs and biologics. The objectives are to improve intercenter communication on combination products, as well as the timeliness and consistency of intercenter consultative and collaborative reviews. The document describes key policies regarding the consultative/collaborative review process, as well as responsibilities and procedures to be followed by those requesting and conducting intercenter reviews. The first revision of this document, effective February 14, 2003, implements interim measures to provide for the tracking of consultative and collaborative reviews of combination products by the Office of Combination Products. The document will continue to be refined and updated.

**Report: Combination Product Review Intercenter Consult Process Study, October 2015 (PDF - 299KB)**

                                                                                  Content current as of:
      04/23/2019Guidance & 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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