A device that

• In order to comply with the order of an individual physician or dentist, deviates from devices generally available, or from an applicable performance standard or premarket approval requirement;
• Is not generally available to, or generally used by, other physicians or dentists;
• Is not generally available in finished form for purchase or for dispensing upon prescription;
• Is not offered for commercial distribution through labeling or advertising; and
• Is intended for use by an individual patient named in the order 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.