FDA Final Guidance Documents on Writing Requests for Product Designation
This post was written by Paul Sheives.
The FDA has released final “Guidance for Industry on How to Write a Request for Designation.” The guidance is intended to help industry understand the type of 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 FDA component for review and regulation. The guidance provides general information about Requests for Designation (e.g., when to submit, how to appeal, meetings with FDA), and also sets forth the detail of what should be provided in a Request for Designation.
