Update August 3, 06

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Update August 3, 06

FDA UPDATE

August 3^rd: Increase Medical Device User Fee Rates for Fiscal Year 2007

We saw it was coming, like everything else it seems these days that the FDA user fees for the medical device industry will also be rising. The FDA just announced their new fees for the coming fiscal year that will start Oct. 1^st, 2006.

The new fees are substantially higher for the coming year: 8.4% higher. For PMA there is an increase of $22,000., the 180-Day supplement a $4730 increase, Real time supplement $934 and for the 510(k) the increase is of $325. (See chart below). For small businesses the increase as similar and will be quite costly.

Full fees:

Applicant fees Type	Fees for FY 2007	Fees for FY 2006
PMA	$281,600	$259,600
180-Day Supplement	$60,544	$55,814
Real Time Supplement	$21,209	$20,275
510(k)	$4,158	$3,833

Fees for small business:

Applicant fees Type	Fees for FY 2007	Fees for FY 2006
PMA	$107,008	$98,648
180-Day Supplement	$23,007	$21,209
Real Time Supplement	$7,705	$7,103
510(k)	$3,326	$3,066

Please be aware that firms with annual gross sales or receipts of $30 million or less, including the gross sales and receipts of all affiliates, partners, and parent firms, may qualify for a fee waiver for their first PMA.

Firms with annual gross sales or receipts of $100 million or less, including the gross sales and receipts of all affiliates, partners, and parent firms, may qualify for lower rates for all applications that are subject to a fee.

Even if a firm qualified under the act as a small business for MDUFMA fees in FY 2005, it must obtain a new small business certification and decision number for FY 2006 and for each subsequent FY. This can be initiated any time after the publication of this notice. A firm that does not have an FY 2006 small business qualification decision number from FDA will not be permitted to submit the reduced small business fees for applications submitted during FY 2006. FDA urges firms to apply for this qualification at least 60 days before they intend to submit their application and fee. To obtain a Small Business Qualification Certification FDA form 3602 has to be submitted along with income tax returns.

FDA must receive the correct fee at the time that an application is submitted, or the application will not be accepted for filing or review.

For complete FDA report of this update, please refer to following links:

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-12394.htm

If you have comments regarding this update, please email us at info@mdiconsultants.com

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