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FDA FY2026 MDUFA User Fee(s) & Establishment Registration Fee
The following table shows the fees per each medical device submission type for FDA fiscal year 2026, beginning Oct 1, 20 […]
EU MDR Transition Success
Class III Implantable Device
Achieved FDA 510(k) clearance in 4 months vs. industry average of 9 months for an innovative diagnostic device.
510(k) Clearance in Record Time
Class II Medical Device
Achieved FDA 510(k) clearance in 4 months vs. industry average of 9 months for an innovative diagnostic device.
QMS Implementation
Startup Medical Software Company
Achieved FDA 510(k) clearance in 4 months vs. industry average of 9 months for an innovative diagnostic device.
EU MDR Transition Success
Class III Implantable Device
Achieved FDA 510(k) clearance in 4 months vs. industry average of 9 months for an innovative diagnostic device.
510(k) Clearance in Record Time
Class II Medical Device
Achieved FDA 510(k) clearance in 4 months vs. industry average of 9 months for an innovative diagnostic device.
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