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FDA Supplements Pre-designation Process for Classifying Combination Products

August 17, 2016

The FDA is tweaking its process for designating which center gets jurisdiction over products that defy easy categorization by offering companies a pre-review pathway.

The pathway, titled the pre-request for designation process, does not replace the more formal FD pathway used by the Office of Combination Products to determine which center should conduct the review, the agency explained.

Rather, the pre-RFD pathway can be used in lieu of it, which agency officials said could benefit companies that favor a more interactive approach to their proposals or in cases when the product is in the early stages of development.

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