Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Public

What Legislation applies?

No Type Device to administer a drug (not integral part of the device) but cross labeled or co-packaged with the device 1.

Example

Device and drug are integral (but not reusable) product. 2.

Device and drug as integral product where the action of the drug is ancillary. 3.

Device and human blood-derived substance (ancillary) as integral product. 4.

Device combined with an Advanced Therapy Medicinal Product (ATMP). 5. Companion diagnostics (CDx): In vitro diagnostic which provides information about drug with which it used. 6.

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Regulatory Approval Process

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