Blogs #FDA regulations
Demystifying Engineering Change Control in the Medical Devices
Engineering change control is a subset of change control that specifically focuses on changes related to product design, development, and manufacturing processes. It is a structured approach to managing changes in engineering documentation, product specifications, drawings, and other technical aspects.
Does an IRB need to review custom use?
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.