Page 17 - Assurance of Sterility for Sensitive Combination Products and Materials
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6 Assurance of sterility for sensitive combination products and materials
i.e., drug/device, biologic/device, drug/biologic, or A product comprised of two or more regulated components, drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single Two or more separate products packaged together in a single package or as a unit and compr
Definition of combination products
(According to the FDA: 21 CFR 3.2(e)) 1. entity; 2. Drug-biologic products; 3. 4.
Biologic Drug-device-biologic
Drug
Device Device-biologic Definition of combination products.
Drug-device Fig. 2.1
