Is it appropriate to use a quality systems approach in the conduct of IVD studies?
Yes, we recommend that sponsors and investigators follow quality systems methodologies, including accountability and traceability of the investigational device, auditing of data collected and monitoring to make sure the protocol was followed, documentation of training of staff in the use of the device [21 CFR 812.43(a)], and notifying FDA of unanticipated adverse device effects 21 CFR 812.150(b)(1) in the conduct of IVD studies. Also, 21 CFR 812.20(b)(3) requires “A description of the methods, facilities, and controls used for the manufacture, processing, packing, storage, and, where appropriate, installation of the device, in sufficient detail so that a person generally familiar with good manufacturing practices can make a knowledgeable judgment about the quality control used in the manufacture of the device.” This suggestion is consistent with both the need to provide scientifically valid information in support of premarket submissions and the design control requirements. Manufacture
