FDA issued a final Guidance “FDA and Industry Procedures forSection 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act” dated April 6, 2012 to replace the April 29, 2010 draft. This guidance is issued jointly by CDRH and CBER. This guidance defines the process for sending in a request to FDA for information regarding the regulatory classification of product including whether FDA considers it a device and if so how it is regulated. There is a user fee for submission of a request.