Immunostimulating hydrogels are a combination product. Hydrogels depending on the peptide structure are chemically synthesized through peptide synthesis. Designer hydrogels can have small growth factors or biologics attached to the peptide strand that then forms into a hydrogel.

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The hydrogel studied here acts a drug delivery vehicle that can transport chemical drugs or biologics to a designated site. The primary mode of action for this device is to deliver a sustained release of drug to the transdermal layer. This product would fall under the CBER regulations because the product is a biologic that aids in transdermal drug delivery. This product will require both in-vitro and in-vivo testing as well as clinical trial process to determine the safety and efficacy on animal and human models.