In 1976, Congress enacted the Medical Device Amendments (MDA). This law, now part of the Federal Food, Drug, and Cosmetic Act (FD&C Act), generally requires FDA clearance or approval before a new device can be marketed in the United States. Congress enacted an exception, however, for custom devices. A device that qualifies as a custom device is exempt from FDA premarket clearance or approval.
The custom device exemption states that a device “which, in order to comply with the order of an individual physician or dentist. . .necessarily deviates from an otherwise applicable performance standard or [premarket approval requirement],” is not subject to performance standards or premarket approval.
However, to be considered custom, a device has to meet certain criteria. According to the FD&C Act, the device should not generally be “available in finished form for purchase or for dispensing upon prescription and is not offered through labeling or advertising.” The device must also be intended for use by an individual patient who is named. In addition, the device must be made in a specific form for that patient, or intended to meet special needs “in the course of the professional practice” of a specific physician or dentist but is “not generally available to or generally used by other physicians or dentists.”1