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Week Ending July 29, 2005

H.R.3423 To amend the Federal Food, Drug, and Cosmetic Act with respect to medical device user fees.

BRIEF

   The bill establishes a schedule of fee increases paid by medical device manufacturing companies to the Department of Health and Human Services, Food and Drug Administration for testing medical devices prior to being released to the market.

  The bill establishes that a small business is one with yearly gross receipts to $100 million rather than the current $30 million.

   To test the devices the FDA has added staff and taken on additional expenses but Congress has not increased funding, therefore the fees charged would be increased to meet those expenses.

   A fee increase example includes an increase of a required fee from $154,000 to $281,600.

Sponsor: Representative Joseph R. Pitts (R-PA-16^th)

Vote: Passed House by unanimous consent (July 26, 2005). Passed Senate by Unanimous Consent (July 27, 2005)

Cost to the taxpayers: No discernible cost.

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