What regulation describes custom devices?

Custom devices are defined in 21 CFR 812.3(b) and section 520(b) of the Federal Food, Drug, and Cosmetic Act. A custom device meets all of the following criteria:

• It is necessarily different from generally available devices or performance standards to meet the order of an individual physician or dentist
• It is not generally available to, or used by, other physicians or dentists
• It is not generally available for purchase or dispensing upon prescription
• It is not offered for commercial distribution
• It is intended for use by an individual patient, or to meet the needs of the individual physician or dentist

FDA regulations do not require review and approval for custom device use. However, FDA recommends putting as many patient protection measures in place 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.