16 C.F.R. § 1632.31
(a) Definitions. For the purposes of this section, the following definitions apply:
(b) Labeling.
(c) Records—manufacturers, importers, or persons initially introducing items into commerce. Every manufacturer, importer, or other person initially introducing into commerce mattresses or mattress pads subject to the standard, irrespective of whether guarantees are issued relative thereto, shall maintain the records hereinafter specified.
(f) “One of a kind” exemption for physician prescribed mattresses and mattress pads.
(1) A mattress or mattress pad manufactured in accordance with a physician's written prescription or manufactured in accordance with other comparable written medical therapeutic specification, to be used in connection with the treatment or management of a named individual's physical illiness or injury, shall be considered a “one of a kind mattress” and shall be exempt from testing under the Standard pursuant to § 1632.2(b)(4) thereof: Provided, that the mattress bears a permanent, conspicuous and legible label which states:
WARNING: This mattress or mattress pad may be subject to ignition and hazardous smoldering from cigarettes. It was manufactured in accordance with a physician's prescription and has not been tested under the Federal Standard for the Flammability of Mattresses (FF 4-72).
Such labeling must be attached to the mattress or mattress pad so as to remain on or affixed thereto for the useful life of the mattress or mattress pad. The label must be at least 40 square inches (250 sq. cm) with no linear dimension less than 5 inches (12.5 cm). The letters in the word “WARNING” shall be no less than 0.5 inch (1.27 cm) in height and all letters on the label shall be in a color which contrasts with the background of the label. The warning statement which appears on the label must also be conspicuously displayed on the invoice or other sales papers that accompany the mattress in commerce from the manufacturer to the final point of sale to a consumer.