Update Aug 02, 04

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Update Aug 02, 04

The FDA is raising the Medical Device User Fee Rates for 2005 - Though only a small Percentage

Inflation has hit the medical device industry again. This increase was not from it’s suppliers or the labor unions but from our government. The industry has just been informed that cost of 510(k)s and PMAs will increase for the coming fiscal year 2005. The FDA has raised the fees on 510(k)s from $3480. to $3502. (a relatively small increase of $.6%) and PMAs from $206,811 to $239,237. (a more substantial $15.7% increase).

The new user fees are as follows:

Fees for Premarket Notification (510(k)s)

For fiscal year 2005 (October 1, 2004 through September 30, 2005), the fee for 510(k) review is the following. [( ) the 2004 fees]

FY 2005 Device Review User Fees (U.S. Dollars)
Application	Standard Fee	Small Business Fee
510(k)	$3,502($3480)	$2,802($2784)

This application fee applies to all 510(k)'s including Traditional, Abbreviated, and Special 510(k)s.

The FY2005 fees apply to applications received on or after October 1, 2004. If the application and payment are received prior to October 1, 2004, applicants should pay the FY 04 fee.

Fees for Premarket Approvals

For fiscal year 2005 (October 1, 2004 through September 30, 2005) the fees for these applications are: [( ) the 2004 fees]

FY 2005 Device Review User Fees (U.S. Dollars)
Application	Standard Fee	Small Business Fee
Premarket Application (PMA, PDP, BLA)	$239,237($206,811)	$90,910($78,588)
Premarket Report (premarket approval application for a reprocessed device)	$239,237	$90,910
First premarket application by a small business	Not applicable	Fee is waived
Panel-track Supplement	$239,237	$90,910
Efficacy Supplement (for BLA)	$239,237	$90,910
180-day Supplement	$51,436($44,464)	$19,546($16896)
Real-time Supplement	$17,225($14,890)	$6,546($5658)

The FY2005 fees apply to applications received on or after October 1, 2004. If the application and payment are received prior to October 1, 2004, applicants should pay the FY 04 fee.

For more information on the FDA User Fees contact the FDA at www.FDA.gov/cdrh/dsma or mdi at Userfees@mdiconsultants.com.

If any questions on the report or comments please email us at info@mdiconsultants.com.

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