Laboratory developed test (LDT) providers, previously exempt from U.S. Food and Drug Administration (FDA) oversight, under a new FDA proposal, must now consider if their LDTs constitute moderate-risk (Class II) or high-risk (Class III) devices that will be subject to FDA oversight.
If so, LDT providers will have to seek FDA approval or clearance through a premarket approval application (PMA) or a 510(k) premarket notification submission. During the 510(k) process, a company asserts that its new device is substantially equivalent to an existing predicate device for the purpose of establishing the safety and effectiveness of the new device.
Originally published in Bloomberg BNA Medical Devices Law & Industry Report on October 28, 2015.
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