Therapeutic or diagnostic items that include pharmaceuticals, medical equipment, and/or biological components are known as combination products. Two or perhaps all three of these product types are included in a Combination of biologic products. A syringe prefilled with medicine and a first-aid kit comprising bandages and pain-relieving drugs is two of the most prevalent forms of drug gadget combo goods.
What Kinds of Combination Products Can You Think of?
Combination biologic products are divided into three categories by the CFR: single entity, co-packaged, and cross-labeled. Single-entity combination products consist of two or more components that are combined or blended to generate one single entity (either medication and a device, a biologic and a device, or all three). The following are examples of single-entity combo products:
Prefilled syringes, injector pens, insulin pumps, and metered dosage inhalers are all examples of prefilled medication delivery systems.
Biologic delivery devices and systems that are prefilled, such as nasal sprays or prefilled syringes with vaccines
Transdermal patch or antibacterial wound dressing coated or otherwise coupled with medication or biologic
Such as an antibody and a medicinal medication in combination.
As the name implies, co-packaged combination products are made up of two or more components that are all contained inside one box or sleeve together. In addition to being known as convenience kits, these product kinds are sometimes referred to as product bundles. Co-packaging may be seen in the following scenarios:
A syringe is included with a drug or vaccination container.
Dose-dispenser for liquid medicine.
Instrument and anesthetic medicine storage tray for the operating room
Devices, drugs, and biological products that are cross-labeled are packed separately and meant to be used only with an authorized independently defined device, medication, or biological product when both components are necessary to accomplish the intended use, indications, or effects. Simply said, these items are marketed individually but are intended for usage in conjunction with one another. The following are a few instances of cross-labeling:
Laser or light source activation with a photosensitizing medication
Biological products are triggered by light but are not packaged along with a particular light source.
Regulatory Requirements for Combination biologic products.
Regulations products include:
Application for premarket approval (PMA), request for the categorization, or 510(k) filing in the case of a PMOA for devices. Biologic licensing application (BLA) if the PMOA is a biologic.