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Capitol Health Call
November 6, 2002

Device Manufacturer Fees

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JAMA. 2002;288(17):2111. doi:10.1001/jama.288.17.2111-JCH20001-2-1

A bill passed by the House of Representatives (HR 3580) would charge medical device manufacturers $139 000 for each product approved by the FDA. The bill was spurred by concerns that the agency takes too long to review applications.

At press time, the Senate had not yet considered its version of the bill, leading to speculation that pressure from device manufacturers would scuttle the legislation. The 1100-member Advanced Medical Technology Association reportedly agreed to the House bill after inclusion of a provision that exempts companies with up to $10 million in annual sales.