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Summary
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Historically, the orthopedic industry has appreciated the difference in the performance data threshold necessary to earn Investigational Device Exemption (IDE) approval versus the threshold to get 510(k) clearance. For IDE approval, a company is attempting to demonstrate to the FDA that a device is safe enough to initiate a clinical study (i.e., offering a reasonable assurance of safety). In contrast, for the 510(k), a company is attempting to demonstrate substantial equivalence (SE) to another device with regard to indications, intended use, labeling, fundamental scientific technology, and performance. The differences between these two concepts have been very simple in the past because most devices were clearly either class II or class III,where their design could clearly distinguish their intended use. However, a new trend is changing the landscape. Now, the same device can follow a class III
IDE/PMA (Investigational Device Exemption/Premarket Approval) pathway or a class II 510(k) pathway depending on small modifications to its intended use and indications.
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