Our RA Manager Song Seto guides you through the FDAs pathway to get your combination product to the US market. Learn more about the combo products pre-market submission reviews and the other mechanism devised by the FDA and things that you should include in your pre-market submission.

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.