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AAMI TIR48:2015

Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination Products

Provides recommendations on the application of CGMPs for drugs, devices, biologics, and human cells, tissues, and cellular and tissue based products during development and marketing of combination products (drugdevice, biologic-device, drug-biologic, or drug-device-biologic), in accordance with the FDA’s final rule (21 CFR Part 4; 78 FR 4307, 2013 - hereafter "The Rule" or "FDA's Final Rule"). These recommendations are intended to inform the adoption and application of CGMPs for combination products.

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