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):
(1) It necessarily deviates from devices generally available or from an applicable performance standard or premarket approval requirement in order to comply with the order of an individual physician or dentist;
(2) The device is not generally available to, or generally used by, other physicians or dentists;
(3) It is not generally available in finished form for purchase or for dispensing upon prescription;
(4) It is not offered for commercial distribution through labeling or advertising; and
(5) It is intended for use by an individual patient named in the order form of a physician or dentist, and is to be made in a specific form for that patient, or is intended to meet the special needs of the physician or dentist in the course of professional practice (such as a particular operating tool).