FDA Premarket Submission Fees

FDA has revised its user fees and added a fee for 513(g) requests (a commonly used mechanism for many types of software related to clinical, laboratory, and hospital information systems). The Federal Register Notice with the rates is attached. This is effective for Fiscal 2008 which begins in October 2007. Small business discounts are also listed for business with revenue under 100 million dollars.

Upcoming Public Courses

No public courses are planned at this time.

If you would like to discuss a private, onsite course, please fill out the form below.

Or just email training@softwarecpr.com for more info.

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