Medical Device User Fee Stabilization Act of 2005
Latest Action
Became Public Law No: 109-43.
Official Summary
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 misbranded any reprocessed single use device unless the device or an attachment identifies the manufacturer of the reprocessed device, or the identity of the manufacturer of the original device is provided by a detachable label intended to be affixed to the medical record of a patient.
GovScope Watchdog™
AI Government Intelligence™The Medical Device User Fee Stabilization Act of 2005 amends the Federal Food, Drug, and Cosmetic Act to revise the structure and administration of user fees related to medical device applications and submissions. It removes certain fee revenue targets and adjustments for fiscal years 2006 and 2007, sets specific premarket application fees for those years, and allows the Secretary of Health and Human Services to use unobligated fee balances from prior years with congressional notification. The bill also raises the threshold for businesses eligible for reduced or waived fees, removes a prior prohibition on fee assessments based on cumulative revenue targets, and requires detailed annual reporting to Congress on fees paid by small businesses and the allocation of fee revenues. Additionally, it establishes labeling requirements for reprocessed single-use medical devices to avoid being deemed misbranded.
This law modifies medical device user fee structures and reporting requirements to stabilize fee revenues and enhance transparency, while setting labeling standards for reprocessed single-use devices.
- Adjusts and stabilizes medical device user fees for fiscal years 2006 and 2007 by removing certain revenue targets and fee adjustments.
- Allows the Secretary of Health and Human Services to use unobligated fee balances from previous years with congressional notice.
- Increases eligibility thresholds for reduced or waived fees for smaller businesses and mandates detailed annual fee reporting to Congress.
- Removes prior restrictions on fee assessments tied to cumulative revenue targets from 2003 to 2006.
- Requires labeling of reprocessed single-use devices to identify the reprocessor or original manufacturer to prevent misbranding.
['Medical device manufacturers, especially small businesses benefiting from increased fee waiver thresholds', 'The Food and Drug Administration (FDA) through stabilized and potentially more flexible fee revenue streams', 'Health and Human Services Secretary with expanded authority to manage fee balances', 'Patients and healthcare providers through clearer labeling of reprocessed single-use devices']
['The elimination of inflation and workload adjustments may affect the adequacy of fee revenues over time.', 'Use of unobligated fee balances could reduce transparency or complicate budget forecasting despite congressional notice requirements.', 'Raising fee waiver thresholds may reduce fee revenue, impacting FDA resources.', 'Labeling requirements for reprocessed devices could impose compliance costs on manufacturers and reprocessors.']
This bill was enacted during the 109th Congress and signed into law on August 1, 2005. It reflects legislative efforts to refine the medical device user fee program under the Federal Food, Drug, and Cosmetic Act, aiming to stabilize fee revenues and improve oversight and transparency of fee collection and use. The law also addresses regulatory concerns related to reprocessed single-use medical devices.
High concern review — 4 hidden impact flags detected
GovScope reviewed 4 policy-risk categories. Hover for a quick definition. Click detected flags for bill-specific details.
['Potential changes in medical device industry behavior due to altered fee structures and labeling requirements.', 'Possible impacts on FDA resource allocation and review timelines depending on fee revenue stability.', 'Increased transparency in fee reporting may influence future legislative oversight and adjustments.', 'Enhanced patient safety and traceability through labeling of reprocessed single-use devices.']
The bill mandates annual reporting to Congress on fees paid by small businesses and certification of fee revenue allocation, which supports transparency and oversight. However, the expanded authority for the Secretary to use unobligated fee balances with only congressional notice may warrant close monitoring to ensure accountability. The removal of fee adjustments tied to inflation and workload could affect long-term funding adequacy for FDA device review functions.
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