The President recently signed an act reauthorizing medical device user fees for fiscal years 2008 - 2012. The legislation - the Medical Device User Fee Amendments of 2007 - is part of a larger bill - the Food and Drug Administration Amendments Act of 2007 (H.R. 3850) - that affects many other FDA programs.

Here are some of the key changes you should be aware of -

* The 2007 Amendments substantially reduce all existing application fees, while providing for new types of medical device user fees.

* The new user fees are for:
o Submission of a 30-day notice.
o Submission of a 513(g) request for classification information.
o An annual fee for periodic reporting on a class III device.
o An annual fee for the registration of a medical device establishment that is a manufacturer, a single-use device reprocessor, or a specification developer.
* All medical device establishments must now register and list by electronic means (through the Internet). The annual registration and listing will now take place from October 1 through December 31 of each year.
* As soon as possible, FDA intends to provide updated guidance on how a business can qualify as a "small business" for FY 2008. If you qualify as a small business for FY 2008, you will be able to pay any FY 2008 fee at the discounted small business rate.
* 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.

The FDA will provide additional information concerning the 2007 Amendments during the coming weeks. Please check this site periodically to learn more:
http://www.fda.gov/cdrh/mdufma/092807-reauthorized.html

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