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.