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FDA gives with one hand and takes with the other - New FDA user fees imposed

The FDA waited until the start of the new fiscal year to make a dramatic announcement which was a little shocking to the medical device industry, especially to the small and start up manufacture. The FDA gave the industry a little gift by reducing the FDA user fees for 510(K)s but then took the gift back by imposing an annual establishment fee for all medical device manufacturers, specification developers and SUD facilities.

The annual registration fee of over $1700 is quite significant when you can be sure that the FDA will probably raise the fee each year and that you will be paying this fee for years to come.

The FDA is also imposing a new fee for 513(G) classification requests. The FDA is allowing foreign manufacturers to qualify for small business discounts as well.

The following are the changes to the various fees and a list of the new imposed fees.

• A fee for each 30-day notice submitted to FDA. A 30-day notice is a notice under section 515(d)(6) of the FD&C Act that is limited to a request to make modifications to manufacturing procedures or methods of manufacture affecting the safety and effectiveness of a device.
• A fee for each 513(g) request for classification information submitted to FDA. This is a request made under section 513(g) of the FD&C Act for information respecting the class in which a device has been classified or the requirements applicable to a device.
• An annual fee for periodic reporting made under a condition of approval of a class III device. This is an annual fee associated with periodic reports required by a premarket application approval order.
• An annual fee for the registration of each medical device establishment. An establishment that is required to register under section 510 of the FD&C Act must pay this annual fee if it is one of the following:
  • A 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.
  • A single-use device reprocessor. — An establishment that performs manufacturing operations on a single-use device that has previously been used on a patient.
  • A 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.

There is no discounted small business fee; every establishment that is required to pay the annual registration fee will pay the same fee.

The new fees for FY 2008 are summarized in the following table:

Guidance on How to Qualify as a “Small Business” for FY 2008 Will Be Available As Soon as Possible

As soon as possible, FDA intends to provide updated guidance on how your business can qualify as a “small business” for FY 2008. The new guidance will be announced on this web page as soon as it is available. If you qualify as a small business for FY 2008, you will be able to pay any FY 2008 fee as the discounted small business rate. You may also be able to receive a waiver of the fee for your first (ever) premarket application (premarket approval application, biologics license application, product development protocol, or premarket report).

Foreign Businesses Can Now Qualify as a “Small Business”

The 2007 Amendments provide a means for a foreign business to qualify as a “small business,” even if it cannot provide a Federal (U.S.) income tax return. The foreign business will have to provide certain information to FDA, including a “National Taxing Authority Certification” from the local equivalent of the U.S. Internal Revenue Service. As soon as possible, FDA intends to provide updated guidance on how your business can qualify as a “small business” for FY 2008. The new guidance will be announced on this web page as soon as it is available.

If you have any questions concerning these fees please contact mdi at info@mdiconsultants.com

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