AAMI TIR48:2015(R2021)
Current
The latest, up-to-date edition.
Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination Products
Hardcopy , PDF
English
26-03-2021
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 (drug-device, 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").
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