FDA Update – August 10, 2009

Back
... Up One Level
Next

Update – August 10, 2009

Notice of Medical Device User Fee Rates for Fiscal Year 2010

FDA has announced the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2010 through a notice in the federal register dated Aug 3, 2009. These fees apply from October 1, 2009, through September 30, 2010. To avoid delay in the review of application, one should pay the fee before or at the time they submit their application to FDA. It also provides information on how the fees for FY 2010 were determined, the payment procedures that needs to be followed, and how one may qualify for reduced small business fees. The fee one must pay is the fee that is in effect on the later of the date that their application is received by FDA or the date on which their fee payment is received.

As you will see on the chart below the FDA is raising all their fees approximately 10%.

It will now cost more for the medical industry. The cost of 510(k)s, 513(g)s and the annual registrations is going up.

Application Fee Types	Standard Fee, as a Percent of the Standard Fee for a Premarket Application	FY 2010 Standard Fee	FY 2010 Small Business Fee
Premarket application (a PMA submitted under section 515(c)(1) of the act (21 U.S.C. 360e(c)(1)), a PDP submitted under section 515(f) of the Act, or a BLA submitted under section 351 of the Public Health Service (PHS) Act (42 U.S.C. 262))	Set in statute	$217,787	$54,447
Premarket report (submitted under section 515(c)(2) of the act)	100%	$217,787	$54,447
Efficacy supplement (to an approved BLA under section 351 of the PHS Act)	100%	$217,787	$54,447
Panel-track supplement	75%	$163,340	$40,835
180-day supplement	15%	$32,668	$8,167
Real-time supplement	7%	$15,245	$3,811
510(k) premarket notification submission	1.84%	$4,007	$2,004
30-day notice	1.6%	$3,485	$1,742
513(g) (21 U.S.C. 360c(g)) request for classification information	1.35%	$2,940	$1,470
Annual fee for periodic reporting on a class III device	3.5%	$7,623	$1,906
Annual establishment registration fee (to be paid by each establishment that is a manufacturer, a single- use device reprocessor, or a specification developer, as defined by 21 U.S.C. 379i(13))	Set in statute	$2,008	$2,008

Information on the How to Qualify as a Small Business for Purposes of Medical Device Fees, Procedures for Paying Application and Annual Report Fees and Procedures for Paying Annual Establishment Fees can be obtained at the link http://edocket.access.gpo.gov/2009/E9-18456.htm

For more information on this article, please email mdi at info@mdiconsultants.com and reference Ranbaxy.

Internet Presence, Creation, Design & Maintenance by: Windco.com, Inc