FDA 2009 Submission User Fees

FDA’s 2009 pre market submission user fees are posted at http://edocket.access.gpo.gov/2008/pdf/E8-17739.pdf. Note that fees have been added for 513(g) requests for classification. These are often used for getting feedback on software products as to their regulatory classification and status.

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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