Till startsidan
Friday 9 January, 2009
NEW POSTAL ADRESS
Business Region Göteborg AB
Box 111 19
SE-404 23 Göteborg
Sweden
Visiting address
Norra Hamngatan 14
Phone: +46 31 61 24 02
Fax: +46 31 61 24 01
New FDA user fees for 2008
A new fee structure for Medical Device Applications, Submissions and Periodic Reporting was introduced by FDA, the American Food & Drug Administration, on 1 October 1.
This includes the introduction of a yearly Establishment Registration Fee of USD 1,706 for each US establishment. For companies selling in the US this registration should be in place.

It should also be noted that  all companies with a class III device will be subject to a annual fee of USD 1,619 for "Small Business" and 6,475 for other companies.

Non-US companies with sales below USD 100 million can apply for the "Small Business Fee", which is a novelty, when applying. A certification from the Swedish tax authorities is needed to varify the below 100 million limit.

The new fee structure will make applications for 510(k) and PMA cheaper.

For more info:
http://www.fda.gov/cdrh/mdufma/

Updated: 20071130