2 minLaboratory Developed TestsThe FDA defines Laboratory Developed Tests (LDTs) as “in vitro diagnostic products (IVDs) that are intended for clinical use and are...
1 min510(k) Clearance Process for Medical DevicesThe 510(k)-review pathway can be used to obtain FDA clearance for a moderate to low-risk device when a predicate device is established.
1 minDe Novo Classification Request for Medical DevicesLow and moderate risk medical devices may require a De Novo Classification Request if there is no predicate or similar established device.