Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Device registration and listing guidance: New 1guidance explains device facility registration and listing procedures established by the FDA Amendments Act of 2007. Since October 2007, domestic device companies and foreign firms that manufacture or process a device sold in the U.S. have had to register and pay an annual facility registration fee for all their establishments, unless a waiver is granted. The Oct. 8 guidance explains the new, online registration and listing process, and the process for requesting a waiver. Registration is complete once the fee is paid, information is submitted online and the company receives notice from FDA. The registration fee for fiscal 2010 is $2,008, rising to $2,179 in FY 2011 and $2,364 in 2012