AAMI TIR48:2015 Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products
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1.1 Inclusions This Technical Information Report (TIR) 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. 1.2 Exclusions The TIR does not address topics outside the realm of CGMPs. Additionally, the TIR may inform practices for combination products marketed outside the United States, but it is not intended, or considered to address non-U.S. requirements comprehensively.