Medical Device User Fee Stabilization Act of 2005

Bill: 109-s-1420
Sponsor: Sen. Enzi, Michael B. [R-WY]
Introduced: 2005-07-18 in the Senate
Policy area: Health
Subjects: Administrative procedure
Appropriations
Biomedical engineering
Collection of accounts
Commerce
Congress
Congressional reporting requirements
Department of Health and Human Services
Economics and Public Finance
Food and Drug Administration (FDA)
Government Operations and Politics
Government publicity
Identification devices
Labeling
Law
Medical supplies
Medical technology
Science, Technology, Communications
Small business
User charges

Summary:
action_date: 2005-07-18
text: 
Medical Device User Fee Stabilization Act of 2005 - Amends the Federal Food, Drug, and Cosmetic Act to adjust the formula for setting medical device user fees (e.g., premarket application, premarket report, supplement, and submission fees).
 
Requires the Secretary of Health and Human Services to grant a waiver of premarket approval fees for small businesses with $75,000,000 (currently, $30,000,000) or less of gross receipts or sales.
 
Deems as misbranded any reprocessed single-use device unless it identifies the manufacturer. Allows the Secretary to waive such identification requirement if compliance: (1) is not feasible due to the device's physical characteristics; or (2) would compromise the provision of reasonable assurance of the device's safety or effectiveness.

action_date: 2005-07-25
text: 
Medical Device User Fee Stabilization Act of 2005 - Amends the Federal Food, Drug, and Cosmetic Act to adjust medical device user 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 its 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 by the Secretary 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.


Legislative actions:
action_date: 2005-07-25
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 173.
action_date: 2005-07-25
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Enzi with an amendment in the nature of a substitute. With written report No. 109-107. Additional views filed.
action_date: 2005-07-25
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Enzi with an amendment in the nature of a substitute. With written report No. 109-107. Additional views filed.
action_date: 2005-07-20
text: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
action_date: 2005-07-18
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2005-07-18
text: Introduced in Senate