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U.S. Department of Health and Human Services

Combination Products

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Intercenter Consultative/Collaborative Review Process

On 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.