Per FDA guidance of Significant Risk and Nonsignificant Risk Medical Device (Jan. 2006) studies, the risk determination of an investigational device is based on the proposed use of a device in an investigation, and not on the device alone. Significant risk studies are those that present a potential for serious risk to the health, safety, or welfare of a subject. IRBs should consider the potential harm the procedure could cause as well as the potential harm caused by the device. Examples of non-significant risk and significant risk devices are listed on the above FDA guidance.
Studies of an already cleared medical device for a new use (off-label) must comply with the human subject protection (informed consent and additional safeguard for children in research are required), IRB, and IDE regulations.
When the off-label use of a legally marketed device is part of a research study collecting safety and effectiveness data involving human subjects, IRB review and approval is required (21 CFR 812.2(a)).
Isolated kidney perfusion and transport system and accessories regulation is covered by 21 CFR 876.5880.
Studies of an already cleared medical device for a new use (off-label) must comply with the human subject protection (informed consent and additional safeguard for children in research are required), IRB, and IDE regulations.
When the off-label use of a legally marketed device is part of a research study collecting safety and effectiveness data involving human subjects, IRB review and approval is required (21 CFR 812.2(a)).
Isolated kidney perfusion and transport system and accessories regulation is covered by 21 CFR 876.5880.
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