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New Guidance for the Industry - How to write a Request for Designation (RFD)

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On Monday, April 18, 2011, the FDA announced the availability of a guidance document for the industry entitled How to Write a Request for Designation (RFD). The guidance (which supersedes the previous RFD guidance document issued in 2005) is intended to
* clarify the type of information that the FDA's Office of Combination Products recommends a sponsor include in an RFD;
* help the sponsor understand what information the FDA requires to determine the regulatory identity or classification of a product as a drug, device, biological product or combination product;
* assign the product to the appropriate agency component for review and regulation.

The full text of the guidance can be found here: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM251544.pdf

RFDs generally request a determination of:
(1) the regulatory identity or classification of a product as a drug, device, biological product, or combination product, and/or
(2) either the component of FDA that will regulate the product if it is a non-combination product,
or which Agency Center will have primary jurisdiction for premarket review and regulation if it
is a combination product.
A letter of designation, (alternatively referred to as a designation letter) is FDA’s formal response to an RFD and is a binding determination.
 
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