Untangling Combination Product Regulations Requires More FDA Guidance

The complex process of regulating combination products begins with the FDA’s determination of which center — CDRH, CBER or CDER — will take the lead role in overseeing a product’s development, but even after that determination is made, the way regulations are applied opens up another layer of complexity.

“At a high level,” says Bradley Thompson, an attorney at Epstein Becker Green, “the biggest problem the industry faces is that there simply aren’t enough FDA guidance documents that explain the rules with regard to combination products.” Because of how much more labor-intensive it is to have the centers work together, he said, “they do not often come up with guidance to help combination product developers,” leaving combination product developers “guessing.”

Additional guidance is most needed, Thompson says, in the areas of essential performance requirements, human factors validation studies, sequential preconditioning, postmarket product modifications and the impact of those changes on submission requirements, and “the applicability of FDA rules to digital drug-device combination products where software is used to guide or somehow facilitate appropriate use of a drug.”

This second of a two-part FDAnews series focuses on problems combination product manufacturers face when dealing with FDA regulations. Read part one by subscribing here.

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