Valid scientific evidence is defined in the “Medical Device Classification
Procedures” regulation, 21 CFR Part 860, as:
Evidence from well-controlled investigations, partially controlled studies, studies
and objective trials without matched controls, well-documented case histories
conducted by qualified experts, and reports of significant human experience with
a marketed device, from which it can fairly and responsibly be concluded by
qualified experts that there is reasonable assurance of the safety and effectiveness
of a device under its conditions of use (21 CFR 860.7(c)(2)).
The intended use of the IVD, the level and quality of information in the literature
relevant to the device use, and FDA knowledge of the technology obtained from
reviewing other premarket applications determine the type of study and the level
of evidence you may need to demonstrate reasonable assurance of its safety and
effectiveness. For example, if you are studying an IVD device that uses a well characterized
technology and has an intended use that falls within a type of device
that has been classified into Class I or Class II, the study may consist of a
comparison of analytic performance to that of a legally marketed (i.e., predicate)
device. On the other hand, if your IVD uses novel or unproven technology or has
a new intended use, you may need to conduct a well-planned clinical study of the
device in the target population defined by your intended use. You may contact the
Division in the appropriate Center if you have questions regarding the type of
study you need to conduct for your device.
We recommend that sponsors and investigators of all studies, including exempt
studies under 21 CFR 812.2(c)(3), conduct the studies with the following goals in
mind: producing valid scientific evidence of the product’s safety and effectiveness
and protecting the rights and welfare of study subjects. Sponsors and investigators
of significant and non-significant risk studies must comply with the regulation
requirements in 21 CFR Part 812. FDA recommends that sponsors and
investigators of studies exempt from the majority of requirements under 21 CFR
Part 812 use the relevant sections of 21 CFR Part 812 regarding the general
conduct of device studies as guidance. (General Regulatory Issues, Section III
of this guidance, discusses how 21 CFR Part 812 may apply to a particular IVD
study.)
