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Device Makers OK Fee Deal With Regulators

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Reuters

Medical device makers said they have reached a deal to pay user fees to U.S. regulators to shorten review times for companies’ products.

AdvaMed, which represents 1,100 device companies, said industry representatives negotiated an agreement on user fees with the Food and Drug Administration. Congress would have to authorize the fees before the FDA could collect them.

Drug makers have paid user fees for 10 years, helping new medicines to reach the market quicker.

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An FDA spokesman said the agency has long supported device user fees but could not confirm a deal had been reached.

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