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MEDICAL DEVICE THIRD PARTY REVIEW

This article was originally published in Clinica

Executive Summary

Over the last five or six years many 510(k) reviews have taken one to two years to clear the FDA premarket notification process. This was especially true for 510(k) notices supported by clinical data - about 10% of all 510(k) submissions. Only recently has the 510(k) backlog and delay to clearance been decreased by Center for Devices and Radiological Health (CDRH) Office of Device Evaluation (ODE) initiatives.

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