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Update Feb 25, 03
The FDA announces the User Fee Procedures on how to make payment.
The February 25, 2003 Federal announcement provided the medical device
industry the requirements of the User Fees for PMAs and 510(k) as well as
tried to answer all the questions on when payment is due and how payment is
to be made.
The following are some of excerpts from the Fed. Announcements that I know
you will find of interest.
VI. When Do I Submit a Fee for an Application Submitted On or After October
1, 2002, and On or Before the Date of Publication of This Notice?
You must pay a fee for any medical device application subject to a fee that
you submitted on or after October 1, 2002 (21 U.S.C. 379j(a)(1)(A)).
(Section III of this document addresses applications exempted from fees and
procedures related to them.) FDA will issue invoices to all applicants who
submitted medical device applications on or after October 1, 2002, and
through the date of this notice. FDA will issue those invoices during March
and April 2003, and payment will be due within 30 days of issuance date. FDA
will include detailed payment instructions with the invoices. Please include
the invoice numbers on all payments submitted in response to these invoices.
VII. When Do I Submit the Fee for Applications Submitted On or After the
Date of Publication of This Notice?
A. Payment Options for Firms Submitting Medical Device Applications between
Today and March 31, 2003.
If you submit a medical device application subject to fees on or after the
date of publication of this notice, and before April 1, 2003, you may
either:(1) Submit the application without first submitting payment, and pay
the fee when an invoice is received; or(2) Pay the fee at the time the
application is submitted.
B. Payment Requirement for Firms Submitting Medical Device Applications On
or After April 1, 2003.
If you submit a medical device application subject to fees on or after April
1, 2003, you must pay the fee for the application at or before the time the
application is submitted. If you have not paid all fees owed, FDA will
consider the application incomplete and will not accept it for filing (21
U.S.C. 379j(f)).
Well, we are in new times and it will cost you more for getting to market.
Who will it hurt, only time will tell. As you know the company never pays
the tax, only by the end user does, as things get passed along. Don’t let
anyone try to convince you this is not a tax, it is.
For a copy of the whole Fed. Register announcement please go to the
following link:
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-4490.html
or contact mdi for more information, at
info@mdiconsultants.com
U.S. AGENT
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