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U.S. Department of Health and Human Services

Combination Products

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RFD Jurisdictional Decisions

Transparency in the jurisdictional decision making process is an goal of FDA.  Accordingly, FDA is providing redacted RFD decision letters and capsular descriptions of jurisdictional determinations for products that have been approved (refer to web pages listed at the left of this page). Such transparency in jurisdictional decision making should result in greater predictability and consistency of decisions, and decrease ambiguity and uncertainty about FDA perspectives. Moreover, as the bases for FDA decision making become clearer, the need for formal RFD’s and informal inquiries covering specific products may be diminished, which should conserve resources for both industry and FDA.