04 Nov

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. IRBs should be familiar with the regulatory requirements for custom devices because physicians or institutions may seek information from the IRB about the use of a custom device in patients at their healthcare facility. IRBs may develop procedures for the use of custom devices to ensure that patient protection measures are thoughtfully carried out. 

Source: USFDA

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