FDA Guidance on Drug, Device, Bioproduct Classification for RFDs Available
The Food and Drug Administration is announcing the availability of a guidance for industry entitled "How to Write a Request for Designation (RFD)," which supersedes the previous RFD guidance document issued in August 2005. The goal of the guidance…
Sign up for a free preview to unlock the rest of this article
If your job depends on informed compliance, you need International Trade Today. Delivered every business day and available any time online, only International Trade Today helps you stay current on the increasingly complex international trade regulatory environment.
is to help a sponsor understand what information FDA needs to determine the regulatory identity or classification of a product as a drug, device, biological product, or combination product, and to assign the product to the appropriate Agency component for review and regulation.