Changes in U.S. Medical Device Establishment Registration and Listings Requirements
On August 2, 2012, the U.S. Food and Drug Administration (“FDA”) issued amended regulations for Medical Device Establishment Registration and Listing. These changes are required by the new U.S. Food and Drug Administration Safety and Innovation Act (“FDASIA”), and are codified in the revised Title 21, Part 807, of the U.S. Code of Federal Regulations.
The following changes will take effect on October 1, 2012:
1) All registered medical device establishments are required to pay an annual FDA registration fee, regardless of establishment type or activities conducted. The fee charged by FDA will be $2,575 for FY 2013.
2) Facilities located outside the U.S. must provide contact information for “any importer of the establishment’s devices that is known to the foreign establishment” and of “each person who imports or offers for import the establishment’s devices into the United States.” (Federal Register, Vol.77, No. 149, Page 45944).
Registrar Corp can assist you to ensure that your payment to FDA is processed properly and that your establishment registration remains active. Registrar Corp can also help you to comply with these new requirements when they become effective.
If you have any question about medical device establishment registration and listings requirements or any FDA regulation, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or call us at +1-757-244-0177.