|
 |
Update – August 4, 2008
User fees for FY 2009 will go up
The FDA has announced that the user fees for the medical
device industry will rise for 2009.
The new fees go into effect as of Oct. 1, 2008 and will remain in effect
through Sept. 30, 2009.
The annual registration fee will now be $1851. There is no
reduction in the registration fee for small businesses. An establishment
must pay the registration fee if it is any of the following types of
establishments:
Manufacturer. An establishment that makes by any means
any article that is a device, including an establishment that sterilizes
or otherwise makes such article for or on behalf of a specification
developer or any other person.
Single-Use Device Reprocessor. An establishment that performs
manufacturing operations on a single-use device that has previously been
used on a patient.
Specification Developer. An establishment that develops specifications
for a device that is distributed under the establishment's name but
which performs no manufacturing, including an establishment that, in
addition to developing specifications, also arranges for the
manufacturing of devices labeled with another establishment's name by a
contract manufacturer.
The following table outlines the new user fees for medical
devices:
| Application Fee Type |
Standard Fee |
Small Business Fee |
| Premarket application,PDP, BLA |
$200,725 |
$50,181 |
| 180-day supplement |
$30,109 |
$7,527 |
| 510(k) premarket notification submission |
$3,693 |
$1,847 |
| 513(g) request for classification information |
$2,710 |
$1,355 |
The following is how a company has to Qualify as a Small
Business for Purposes of Medical Device Fees
If your business has gross receipts or sales of no more than $100
million for the most-recent tax year, you may qualify for reduced small
business fees. If your business has gross sales or receipts of no more
than $30 million, you may also qualify for a waiver of the fee for your
first premarket application (PMA, PDP, or BLA) or premarket report. You
must include the gross receipts or sales of all of your affiliates along
with your own gross receipts or sales when determining whether you meet
the $100 million or $30 million threshold. If you want to pay the small
business fee rate for a submission, or you want to receive a waiver of
the fee for your first premarket application or premarket report, you
should submit the materials showing you qualify as a small business 60
days before you send your submission to FDA. If you make a submission
before FDA finds that you qualify as a small business, you must pay the
standard fee for that submission.
REMEMBER: If your business
qualified as a small business for FY 2008, your status as a small
business will expire at the close of business on September 30, 2008. You
must re-qualify for FY 2009 in order to pay small business fees during
FY 2009.
If you are a domestic (U.S.) business,
and wish to qualify as a small business for FY 2009, you must submit the
following to FDA:
(1) A completed FY 2009 MDUFMA Small Business Qualification
Certification (Form FDA 3602). This form is provided in FDA's guidance
document, ``FY 2009 Medical Device User Fee Small Business
Qualification and Certification,'' available on FDA's Internet site at
http://www.fda.gov/cdrh/mdufma. This form is not available separate
from the guidance document.
(2) A certified copy of your Federal (U.S.) Income Tax Return for the
most recent tax year. The most recent tax year will be 2008, except--
If you submit your FY 2009 MDUFMA Small Business Qualification before
April 15, 2009, and you have not yet filed your return for 2008, you may
use tax year 2007.
If you submit your FY 2009 MDUFMA Small Business Qualification on or
after April 15, 2008, and have not yet filed your 2008 return because
you obtained an extension, you may submit your most-recent return filed
prior to the extension.
(3) For each of your affiliates, either--
If the affiliate is a domestic (U.S.) business, a certified copy of the
affiliate's Federal (U.S.) income tax return for the most recent tax
year, or
If the affiliate is a foreign business and cannot submit a Federal
(U.S.) Income Tax Return, a National Taxing Authority
Certification completed by, and bearing the official seal of, the
National Taxing Authority of the country in which the firm is
headquartered. This certification must show the amount of gross receipts
or sales for the most recent tax year, in both U.S. dollars and the
local currency of the country, the exchange rate used in converting the
local currency to U.S. dollars, and the dates of the gross receipts or
sales collected. The applicant should also submit a statement signed by
the head of the applicant's firm or by its chief financial officer that
the applicant has submitted certifications for all of its affiliates,
identifying the name(s) of each affiliate(s), or that the applicant has
no affiliates. The National Taxing Authority is the foreign equivalent
of the U.S. Internal Revenue Service.
For Foreign Business to qualify as a small
business:
If you are a foreign business, and wish to qualify as a small business
for FY 2009, you must submit the following:
(1) A completed FY 2009 MDUFMA Foreign Small Business Qualification
Certification (Form FDA 3602A). This form is provided in FDA's guidance
document, ``FY 2009 Medical Device User Fee Small Business
Qualification and Certification,'' available on FDA's Internet site at
http://www.fda.gov/cdrh/mdufma. This form is not available separate
from the guidance document.
(2) A National Taxing Authority Certification, completed by, and bearing
the official seal of, the National Taxing Authority of the country in
which the firm is headquartered. This Certification must show the amount
of gross receipts or sales for the most recent tax year, in both U.S.
dollars and the local currency of the country, the exchange rate used in
converting the local currency to U.S. dollars, and the dates of the
gross receipts or sales collected.
(3) For each of your affiliates, either--
If the affiliate is a domestic (U.S.) business, a certified copy of the
affiliate's Federal (U.S.) Income Tax Return for the most recent tax
year (2007 or later), or
If the affiliate is a foreign business and cannot submit a Federal
(U.S.) Income Tax Return, a National Taxing Authority Certification
completed by, and bearing the official seal of, the National Taxing
Authority of the country in which the firm is headquartered. This
certification must show the amount of gross receipts or sales for the
most recent tax year, in both U.S. dollars and the local currency of the
country, the exchange rate used in converting the local currency to U.S.
dollars, and the dates for the gross receipts or sales collected. The
applicant should also submit a statement signed by the head of the
applicant's firm or by its chief financial officer that the applicant
has submitted certifications for
all of its affiliates, identifying the name(s) of each affiliate(s), or
that the applicant has no affiliates. The National Taxing Authority is
the foreign equivalent of the U.S. Internal Revenue Service.
For more information on this please contact mdi at
info@mdiconsultants.com.
|
 |
