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

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

October 13-15, 2026

Limited Early Bird Registration: $995 / person
Non refundable but transferable.

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

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