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U.S. Department of Health and Human Services

Combination Products

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Redacted Decision Letters

RFD Jurisdictional Decisions

The Agency believes it is very important to provide robust transparency in jurisdictional decision making. Such transparency should result in greater predictability and consistency of decisions, and decrease ambiguity and uncertainty about Agency perspectives. Moreover, as the basis for Agency decision making becomes clearer, the need for formal Requests for Designation (RFD’s) and informal inquiries covering the jurisdiction for specific products may be diminished, which should help to conserve resources for both industry and the Agency.

To this end, once the product covered by an RFD has been approved or cleared, the Office of Combination Products (OCP) will ordinarily post on this website its written jurisdictional determination respecting the RFD, redacted to remove trade secret and confidential commercial information in accordance with the Freedom of Information Act.

It should be noted that, in some cases, products undergo changes in name, sponsor, design or other key aspects following FDA’s issuance of an RFD decision. FDA will post RFD decision letters when it can be sure that the covered product has been approved or cleared, but it should be recognized that the posting may be incomplete. OCP will continue to post RFD decision letters as it becomes aware that products covered by past decisions have been approved or cleared.

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RFD Decision Letters

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