Table 9.

Patient-Centric Custom Device: Requirements

Modified in response to an order of a qualified provider

“Necessarily deviates”∗ from an otherwise applicable performance standard such that investigations would be impractical

Not generally available for commercial distribution in the United States from a manufacturer, importer, or distributor

Designed to treat a unique pathological or physiological condition, or intended for use by a single patient named in the order of the qualified practitioner

Assembled from components made on a case-by-case basis

Intended for treatment of a “sufficiently rare”† condition

Produced in fewer than 5 units per yr‡

FDA = U.S. Food and Drug Administration.

^∗“Necessarily deviate” is defined by the FDA as a device that is modified to be sufficiently unique that clinical investigations would be impractical and could not be done to prove conformance to applicable performance standards and/or to support a premarket review.

^†”Sufficiently rare condition” is defined by the FDA as a condition in a patient population in which the incidence and prevalence is so small that conducting clinical trials would be impractical.

^‡See text for further details defining 5 units per yr.