No. The goals for IVD studies are the same as the goals for other device studies,
even if the IVD study is exempt from most IDE requirements under 21 CFR
812.2(c)(3). We recommend that the sponsor and the investigators conduct an
IVD device study with the goals of:
• producing valid scientific evidence (for a definition, see 21 CFR
860.7(c)(2) and answer #1 of section IV) demonstrating reasonable
assurance of the safety and effectiveness of the product, as described
below, and
• protecting the rights and welfare of study subjects.
