Increased FDA User Fees Effective October 1

FDA raised the Medical Device User Fees by 8-9% and also implemented a new payment system for registration fees. Establishment Registrations must be paid in full and entered into the system by December 31, 2008.

Increased Fees

· Establishment Registration - $1,851

· 510(k) - $3,693/ $1,847 Small Business

· 513(g) - $2,710/ $1,355 Small Business

· PMA - $200,725/ $50,181 Small Business

· PMA Supplement - $150,544/ $37,636 Small Business

· BLA Supplement - $200,725/ $50,181 Small Business

· 180-day Supplement - $30,109/ $7,527 Small Business

· Real-time Supplement - $14,051/ $3,513 Small Business

· 30-day Notice - $3,212 / $1,606 Small Business

· Class III Annual Report - $7,025/ $1,756 Small Business

New Payment Process

FDA now requires that the Establishment Registration fee ($1,851) be paid prior to registering the facility. To help facilitate this new payment requirement, FDA has developed a Facility User Fee website where an account must be created by the firm and then payment is processed either by credit card or electronic check. A mailed check is still accepted by FDA; however, the processing time of the payment should be taken into account.