This is an important update for all importers who have registered Medical Device Establishments with the FDA. Owners or operators of businesses that are involved in the production and distribution of medical devices intended for use in the United States are required to register their establishment with FDA on an annual basis. FDA has made two changes for their fiscal year 2013 (actually begins October 1, 2012).
1.) The biggest change has to do with whom is required to pay the fee. In the past, initial distributors / importers in the United States were required to register, but were not required to pay the registration fee. As of October 1, 2012, this will no longer be the case. ALL establishments, both domestic and foreign, will be required to pay the annual registration user fee.
2.) The registration user fee is increasing from $2029 (FY 2012) to $2575 (FY2013).
Additional information can be found on the following FDA website: http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm314844.htm
Please be aware of these important changes as the Establishment Registration must be kept up to date in order to help ensure a smooth FDA review process.