Medical Device User Fee Stabilization Act of 2005

Summary

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.

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Documents

6 official files

• Reported to Senate (text)

  Reported to Senate · EN · 25 July 2005

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• Reported to Senate (PDF)

  Reported to Senate · EN · 25 July 2005

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• Reported to Senate with amendment(s)

  summary · EN · 25 July 2005

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• Introduced in Senate (text)

  Introduced in Senate · EN · 18 July 2005

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 18 July 2005

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• Introduced in Senate

  summary · EN · 18 July 2005

  Open at official source

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