ISO研修、ISOセミナー:ISO9001、ISO14001、ISMS、OHSAS、シックスシグマのことなら、グローバルテクノ
株式会社グローバルテクノ株式会社グローバルテクノ IRCA認定 審査員研修機関 JRCA承認 ISO9000/ISMS審査員研修コース開催 CEAR承認 ISO14001審査員研修コース開催 SEA/J認定校 ITCA認定研修機関
〒164-0001 東京都中野区中野5-5-11 フリーダイヤル 0120-74-9001
ISO情報 セミナー 認証サービス 講師派遣 出版 お申込・問合せ 資料請求 割引制度 交通アクセス 会社概要

TOP PAGE > 研修・セミナー > FDA(Food and Drug Administration)コース > IMPORTANT INFORMATION ON THE MEDICAL DEVICE USER FEE RATES FOR FY 2006

ISO研修・ISOセミナー

back

IMPORTANT INFORMATION ON THE MEDICAL DEVICE
USER FEE RATES FOR FY 2006
AUGUST 2005

 

Dear Registered Establishment:
The Food and Drug Administration (FDA) is
publishing the fee rates and payment procedures for medical device user fees
for fiscal year (FY) 2006. The Federal Food, Drug, and Cosmetic Act (FD&C),
as amended by the Medical Device User Fee and Modernization Act of 2002
(MDUFMA) and the Medical Device User Fee Stabilization Act of 2005 (MDUFSA)
authorizes FDA to collect user fees for certain medical device applications.
These fees apply to Premarket Approvals (PMAs), Product Development
Protocols (PDPs), Premarket Reports (PMRs), Biologics Licensing Applications
(BLAs for certain medical devices reviewed by FDA's Center for Biologics
Evaluation and Research), some supplements, and Premarket Notifications
[510(k)s].
The fee must be paid for the above listed
applications, unless the applicant is eligible for a waiver or exemption.
Small businesses may qualify for a waiver or a reduced fee.
Note: Important new information regarding
the definition of a small business for FY2006 and 2007.
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 all affilitates, partners,
and parent firms, may qualify for a reduced fee for all applications that
are subject to a fee.
Payment must be received on or before the
time the application is submitted. If the applicant has not paid all fees
owed, FDA will consider the application incomplete and will not accept it
for filing or review.
Fees for Premarket Notification [510(k)s]
For fiscal year 2006 (October 1, 2005
through September 30, 2006), the fee for 510(k) review is the following.
FY 2006 Device Review User Fees (U.S. Dollars)

Application 510(k)
Standard Fee $3,833
Small Business ($100 million in gross
receipts or sales) Fee $3,066

The FY2006 fees apply to applications
received on or after October 1, 2005. If the application and payment are
received prior to October 1, 2005, applicants should pay the
FY05 fee.
Do NOT send payment to FDA with your
application. Additional information, including instructions on how and
where to send payment and how to qualify as a small business, is available
at <http://www.fda.gov/cdrh/devadvice/314a.html>.
This application fee applies to all 510(k)'s
including Traditional, Abbreviated, and Special 510(k)s.
Fees for Premarket Approvals
For fiscal year 2006 (October 1, 2005 through
September 30, 2006), the fees for these applications are:
FY 2006 Device Review User Fees (U.S. Dollars)
Application Standard Fee Small Business
Premarket Application (PMA, PDP, BLA, PMR) $259,600 $98,648

Panel-track Supplement $259,600 $98,648
Efficacy Supplement (for BLA) $259,600 $98,648
180-day Supplement $55,814 $21,209
Real-time Supplement $18,691 $7,103

NOTE: First premarket application from firms with gross receipts or sales
$30 million Fee is Waived
As of October 1st Small Business is defined as ($100
million in gross receipts or sales)

The FY2006 fees apply to applications received on or after October 1, 2005.
If the application and payment are received prior to October 1, 2005,
applicants should pay the FY 05 fee.

Do NOT send payment to FDA with your application. Additional information,
including instructions on how and where to send payment and how to qualify
as a small business, is available at
<http://www.fda.gov/cdrh/devadvice/pma/userfees.html>
Fees for FY 2007 and subsequent years will be
published in the Federal Register 60 days before the start of each fiscal
year.
The Division of Small Manufacturers, International
and Consumer Assistance (DSMICA)
<http://www.fda.gov/cdrh/devadvice/36f.html> can answer questions concerning
the new law and help you find guidance documents and other reference
materials. DSMICA can be contacted by phone at 800-638-2041 or 301-443-6597
or by email at DSMICA@CDRH.FDA.GOV <mailto:DSMICA@CDRH.FDA.GOV>. Questions
regarding products regulated by the Center for Biologics Evaluation and
Research should be directed to the Office of Communication, Training and
Manufacturers Assistance (OCTMA). OCTMA can be contacted by phone at (301)
827-2000 or (800) 835-4709 or by email at MATT@CBER.FDA.GOV

Further information regarding FY2006 User Fees is
available at: <http://www.fda.gov/OHRMS/DOCKETS/98fr/05-15863.htm>, while
additional information about the Medical Device User Fee and Modernization
Act is available at: http://www.fda.gov/cdrh/mdufma/index.html.

Sincerely yours,

John F. Stigi

Director, DSMICA

Center for Devices and Radiological Health

U.S. Food and Drug Administration



TOP PAGE
関連情報
FDA各種コンサルティング
FDA入門コース(企業内セミナー)
医療機器のQSR(FDA品質システム規則)解説コース(企業内セミナー)
FDAとは
FDA用語集

copyright (C) GLOBAL TECHNO Inc.
TOP PAGEへ戻る