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Reauthorized Medical Device User Fees for FY 2008 - 2012

The legislation on the Medical Device User Fee Amendments of 2007 (MDUFA), is part of a larger bill — the Food and Drug Administration Amendments Act of 2007 (H.R. 3850) and according to this, a substantial reduction for all existing application fees have been proposed, while providing for new types of medical device user fees.
The new user fees are proposed for:
• Submission of a 30-day notice.
• Submission of a 513(g) request for classification information.
• An annual fee for periodic reporting on a class III device.
• An annual fee for the registration of a medical device establishment that is a manufacturer, a single-use device reprocessor, or a specification developer.
On the other hand all existing application fees are substantially reduced for PMA, Panel-track PMA Supplement, BLA Efficacy Supplement, as well as 510(k) Notification remarkably for small businesses in a range between -18 – 70%.

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Medical Device User Fees Have Been Reauthorized for Fiscal Years 2008 - 2012

BayBiotech.NET

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