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. Manufacturers of Class II and Class III IVD
devices, and some Class I devices, are required to follow design controls, as
described in 21 CFR 820.30 of the “Quality System Regulation,” during the
development of investigational devices. 21 CFR 812.1(a). See the Glossary for
the definition of device classes.
