United States: Announcements From FDA On Device And Drug User Fees; Public Workshop On In-Vitro Analysis Of Cell/Scaffold Medical Products

On October 12, 2007, the U.S. Food and Drug Administration (FDA) published several announcements in the Federal Register. Two announcements describe new amounts for user fees that must be submitted with applications to the FDA to produce or market medical devices or drugs, and another announcement describes a "public workshop" on the evaluation of cell/scaffold medical products.

Pursuant to the Food and Drug Administration Amendments Act of 2007 ("FDAAA"), the medical device user fees that will be in effect for federal fiscal year (FY) 2008 (October 1, 2007 through September 30, 2008) are being dramatically reduced as compared to FY 2007, in many cases resulting in fees that are less than half of their prior amounts.

There are also a variety of new, relatively small, fees being instituted, most notably an "establishment fee" and a "513(g)" fee. For all of the fees except the establishment fee, "small" businesses (with annual revenue of less than $100 million) pay half or less than half of the amount charged to "large" businesses. Every medical device manufacturer, "single-use device reprocessor", or "specification developer", regardless of size, will now be required to pay a uniform annual business registration ("establishment") fee of $1,760. FDA also announced a fee of between $1,249 (for "small" businesses) and $2,498 (for large businesses) for the "513(g)" process by which an entity may request FDA's assistance in classifying a device to determine the appropriate FDA approval or clearance process the device must undergo prior to being marketed in the U.S.

In contrast to the medical device user fees, the FY 2008 prescription drug user fees have been increased by 25- 31 percent over the FY 2007 fees, and there is no fee reduction for "small" businesses.

The FDA also announced a "public workshop" to be held on December 6 and 7, 2007, during which FDA and the National Institute of Standards and Technology will "discuss issues that should be considered when evaluating cell/scaffold medical products and to determine which test methods are currently available and which new analytical procedures should be further researched for the evaluation of cell/scaffold medical products." The Workshop is open to the public, and prior registration is recommended.

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