Are there different goals for IVD studies compared to other device studies?
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. (See Human Subject Protection, Section V of this guidance). • What regulations describe the content requirements for IVD premarket submissions? Regulations that describe the basic content requirements by submission type include: • Investigational Device Exemption (IDE) – 21 CFR 812.20 • Premarket Notification (510(k)) – 21 CFR 807.87 • Premarket Approval (PMA) – 21 CFR 814.20 • Humanitarian Device Exemption (HDE) – 21 CFR 814.104 Currently, there is no regulat
Related Questions
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- Are there different goals for IVD studies compared to other device studies?
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