16 C.F.R. § 1633.13 – Tests for guaranty purposes, compliance with this section, and “one of a kind” exemption.

(a) Tests for guaranty purposes. Reasonable and representative tests for the purpose of issuing a guaranty under section 8 of the Flammable Fabrics Act, 15 U.S.C. 1197, for mattress sets subject to the Standard shall be the tests performed to show compliance with the Standard.
(b) Compliance with this section. No person subject to the Flammable Fabrics Act shall manufacture for sale, import, distribute, or otherwise market or handle any mattress set which is not in compliance with the provisions under Subpart B.
(c) “One of a kind” exemption for physician prescribed mattresses.
1. (1)
  1. (i) A mattress set 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 illness or injury, shall be considered a “one of a kind mattress” and shall be exempt from testing under the Standard pursuant to § 1633.7 thereof: Provided, that the mattress set bears a permanent, conspicuous and legible label which states:
    WARNING: This mattress set may be subject to a large fire if exposed to an open flame. It was manufactured in accordance with a physician's prescription and has not been tested under the Federal Standard for the Flammability (Open-Flame) of Mattress Sets (16 CFR part 1633).
  2. (ii) Such labeling must be attached to the mattress set so as to remain on or affixed thereto for the useful life of the mattress set. 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 set in commerce from the manufacturer to the final point of sale to a consumer.
2. (2) The manufacturer of a mattress set exempted from testing under this paragraph (c) shall, in lieu of the records required to be kept by § 1633.10, retain a copy of the written prescription or other comparable written medical therapeutic specification for such mattress set during a period of three years, measured from the date of manufacture.
3. (3) For purposes of this regulation the term physician shall mean a physician, chiropractor or osteopath licensed or otherwise permitted to practice by any State of the United States.