ADVANTAGES

For fiscal year 2003 (October 1, 2002 through September 30, 2003), the fee for 510(k) review is $2187. The application fee applies to Traditional, Abbreviated, and Special 510(k)s. Additional information on medical device user fees, including how to qualify as a small business, is available at . Please note that FDA policy on issues related to medical device user fees is still under development. FDA will post policy issues with respect to user fees on the user fee website as it becomes available.

Most Class I devices and some Class II devices are exempt from the Premarket Notification 510(k) submission. A list of exempt devices is located at:

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