Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

Drug-device combinations

FDA examples • “single-entity” combination products Device coated or impregnated with a therapeutic drug product ● Drug-eluting stent (e.g. sirolimus-eluting coronary stent)

● Pacemaker lead with steroid-coated tip ● Catheter with an antimicrobial coating ● Condom with spermicide ● Transdermal patch

Prefilled drug delivery systems ● Syringes, insulin injector pens, metered dose inhaler

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Drug-device combinations

FDA examples (continued) • “co-packaged” combination products ● Drug or vaccine packaged with a delivery device ● Surgical tray with surgical instruments, drapes and anaesthetic or antimicrobial swabs ● First aid kits containing devices (bandages, gauze) and drugs (antibiotic ointments, pain relievers)

“Cross-labeled” combination products ● Photosensitising drug and activating laser / light source

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