How the FDA Defines Combination Products

Is your product a combination product?  Combination products are defined in 21 CFR 3.2(e) and more products than ever now fall into this category but many manufacturers are unaware of that fact nine types of combination products.  The FDA identifies.Take a look at the table below to see if your product might just be a combination product.

Looking to keep your combination product development moving along?


A comprehensive process is needed to make sure your combination product development project finishes on time and on budget. This comprehensive checklist identifies the key phases and work packages to help you stay on track.