Combination Product Testing
The FDA defines a combination product under 21 CFR 3.2A as a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.
Examples of combination products include drug-eluting stents, catheters with antimicrobial coatings, prefilled syringes, insulin injector pens, metered dose inhalers, and transdermal patches.
The rapidly accelerating demand for these sophisticated products continues to fuel innovation and create many exciting opportunities that will bring promising new options to the medical community in advancing patient care and outcomes. The convergence of drugs/biologics and devices also brings a host of new challenges in product development and testing.
As combination products become more prevalent in the pharmaceutical and medical device industries, choosing the right testing partner is an important component to the overall success of your program. DDL provides years of experience in conducting studies for many types of combination products and their components, including:
Some of the many areas that DDL can support are:
Please contact us for more information on combination product testing.