Module 18 2021

07/02/2021

USA Combination product - definition 21 CFR § 3.2 (e) (1) A product comprised of two or more regulated components i.e., drug/device, biological/device, drug/biological, or drug/device/biological …combined as a single entity

(2) Two or more separate products packed together in a single package or as a unit…

(3) A drug, device, or biological product packaged separately that according to its investigational plan or proposed labelling is intended for use only with an approved individually specified drug, device, or biological product… (4) Any investigational drug, device, or biological product packaged separately that according to its proposed labelling is for use only with another individually specified investigational drug, device, or biological product…

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US FDA : Office of Combination Products (OCP)

• Established in 2002 • Important contact point

• Determine - CDER, CDRH or CBER lead review process • Facilitates interaction between different review centers internally • Website – Combination products https://www.fda.gov/combination-products

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