A clinical trials register is the formal record of an internationally agreed minimum amount of information about a clinical trial. This record is usually stored in and managed using a database. A clinical trials registry is the entity that houses the register
All clinical trials meeting the above definition should be registered. Thus, early and late trials, trials of marketed or non-marketed products, randomized or non-randomized trials -- all should be registered.
For the purposes of registration, a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.
FDA regulations do not require review and approval for custom device use. However, FDA recommends that as many of the patient protection measures listed in paragraph 16 be followed as possible.
To be considered a custom device, the device must meet all of the following criteria, which are described in section 520(b) of the act and at 21 CFR 812.3(b)
Yes, FDA recognizes that there are circumstances in which an investigational device is the only option available for a patient faced with a serious or life-threatening condition (hereinafter referred to as "compassionate use").
In general, an unapproved medical device may be used only on human subjects when the device is under clinical investigation and when used by investigators participating in a clinical trial
Yes. During FDA’s review of the premarket notification submission, the device remains an investigational product.
There are three types of studies described in the regulations at 21 CFR Part 812: significant risk (SR) device studies, non-significant risk (NSR) device studies, and exempt studies
In accordance with section 520(g) and the regulations, clinical studies of medical devices must comply with FDA’s human subject protection requirements (informed consent and additional safeguards for children in research) (21 CFR Part 50), Institutional Review Board (IRB) requirements
The act and the HDE regulations do not require informed consent. Because an HDE provides for marketing approval, use of the HUD does not constitute research or an investigation which would normally require consent from the study subjects.
Initial review: Initial IRB approval should be performed at a convened IRB meeting. The IRB does not need to review and approve individual uses of an HUD, but rather the IRB may approve use of the device as it sees fit.