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H.R. 3423 (109th): Medical Device User Fee Stabilization Act of 2005

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The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.


8/1/2005--Public Law. Medical Device User Fee Stabilization Act of 2005 - Amends the Federal Food, Drug, and Cosmetic Act to adjust medical device user fees (e.g., premarket application, premarket report, supplement, and submission fees).

Repeals the fee revenue target amounts for FY2006 and FY2007.

Eliminates the inflation, workload, compensating, and final year adjustments of revenues used for setting fees.

Sets the premarket application fee for devices for FY2006 and FY2007.

Allows the Secretary of Health and Human Services to use unobligated carryover balances from fees collected in previous fiscal years with notice to the appropriate congressional committees.

Increases the annual gross receipts or sales threshold below which businesses are eligible for reduced fees or a waiver of fees by the Secretary.

Removes the prohibition against the Secretary assessing fees unless certain cumulative fee revenues were met for FY2003 through 2006.

Requires the Secretary to include in annual reports to Congress: (1) information on the number and total amount of fees paid for each different type of application or notification from small businesses; and (2) a certification that the amounts obligated for the performance of functions other than the review of device applications is not less than such amount for FY2002 multiplied by the adjustment factor.

Deems as branded any reprocessed single use device unless it identifies the manufacturer, but allows such information to be provided by a detachable label intended to be affixed to the medical record of a patient.