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U.S. Food & Drug Administration

Federal government offices in Dallas, United States
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Examples of co-packaged combination products (the components are packaged together) (21 CFR 3.2 (e) (2)): Example a of product that may be …

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Q:
When should I request input from OCP regarding the classification or center assignment for my medical product?
A:
Premarket Review and Postmarket Regulation of Combination Products
A:
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