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FDA releases 2009 medical device user fees

Device Regulation Alert: Safety, Compliance and Reimbursement News, August 11, 2008

Medical device companies will pay $200,725 for pre-market submissions to the FDA for fiscal year 2009, according to the Federal Register. The FDA calculates other fees as a percentage of the pre-market submission fee.

• A panel-track supplement, 75% of the base fee
• A 180-day supplement, 15% of the base fee
• A real-time supplement, 7% of the base fee
• A 30-day notice, 1.6% of the base fee
• A 510(k) pre-market notification, 1.84% of the base fee
• A 513(g) request for classification information, 1.35% of the base fee
• An annual fee for periodic reporting concerning a class III device, 3.5% of the base fee

All businesses pay the same pre-market submission fee. Qualified small businesses pay a reduced fee for other types of submissions.   

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