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Its pathophysiology is primarily caused by uncontrolled immune system activation, specifically T cell and B cell malfunction, which leads to an overabundance of autoantibodies and immune complex deposition, both of which cause tissue damage

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doi: 10.1007/s12035-025-05068-0

Additionally, titles are minimized, therefore where something is noted as insufficient, this may range from no procedures covering a topic, to procedures not including certain required information, to the company not completely following a procedure

This premarket notification gives FDA time to determine whether the device is substantially equivalent to its predicate device (a device already on the market)