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.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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

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