21 C.F.R. § 860.84 Classification procedures for “preamendments devices.”
(a) This subpart sets forth the procedures for the original classification of a generic type of device that was in commercial distribution before May 28, 1976. Such a device will be classified by regulation into either class I (general controls), class II (special controls) or class III (premarket approval), depending upon the level of regulatory control required to provide reasonable assurance of the safety and effectiveness of the device (§ 860.3(c)). This subpart does not apply to a device that is classified into class III by statute under section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act because the Food and Drug Administration has determined that the device is not “substantially equivalent” to any device subject to this subpart or under section 520(l)(1) of the Federal Food, Drug, and Cosmetic Act because the device was regarded previously as a new drug. In classifying a preamendments device to which this section applies, the Food and Drug Administration will follow the procedures described in paragraphs (b) through (g) of this section.
(b) The Commissioner refers the device to the appropriate classification panel organized and operated in accordance with section 513 (b) and (c) of the Federal Food, Drug, and Cosmetic Act and part 14 of this chapter.
(c) In order to make recommendations to the Commissioner on the class of regulatory control (class I, class II, or class III) appropriate for the device, the panel reviews the device for safety and effectiveness. In so doing, the panel:
(1) Considers the factors set forth in § 860.7 relating to the determination of safety and effectiveness;
(2) Determines the safety and effectiveness of the device on the basis of the types of scientific evidence set forth in § 860.7; and
(3) Provides, to the maximum extent practicable, an opportunity for interested persons to submit data and views on the classification of the device in accordance with part 14 of this chapter.
(d) Based upon its review of evidence of the safety and effectiveness of the device, and applying the definition of each class in § 860.3(c), the panel submits to the Commissioner a recommendation regarding the classification of the device. The recommendation will include:
(1) A summary of the reasons for the recommendation;
(2) A summary of the data upon which the recommendation is based;
(3) An identification of the risks to health (if any) presented by the device;
(4) In the case of a recommendation for classification into class I, a recommendation as to whether the device should be exempted from the requirements of one or more of the following sections of the Federal Food, Drug, and Cosmetic Act: Section 510 (registration, product listing, and premarket notification), section 519 (records and reports), and section 520(f) (good manufacturing practice requirements of the quality system regulation) and, in the case of a recommendation for classification into class II, whether the device should be exempted from the premarket notification requirement under section 510, in accordance with § 860.15;
(5) In the case of a recommendation for classification into class II or class III, to the extent practicable, a recommendation for the assignment to the device of a priority for the application of a performance standard or a premarket approval requirement, and in the case of classification into class II, a recommendation on the establishment of special controls and whether the device should be exempted from premarket notification in accordance with § 860.15; and
(6) In the case of a recommendation for classification of an implant or a life-supporting or life-sustaining device into class I or class II, a statement of why premarket approval is not necessary to provide reasonable assurance of the safety and effectiveness of the device and an identification of the risks to health, if any, presented by the device, in accordance with § 860.10.
(e) A panel recommendation is regarded as preliminary until the Commissioner has reviewed it, discussed it with the panel if appropriate, and published a proposed regulation classifying the device. Preliminary panel recommendations are filed at Dockets Management Staff upon receipt and are available to the public at https://www.regulations.gov.
(f) The Commissioner publishes the panel's recommendation in the Federal Register, together with a proposed regulation classifying the device, and other devices of that generic type, and provides interested persons an opportunity to submit comments on the recommendation and proposed regulation.
(g) The Commissioner reviews the comments and issues a final regulation classifying the device and other devices of that generic type. The regulation will:
(1) If classifying the device into class I, prescribe which, if any, of the requirements of sections 510, 519, and 520(f) of the Federal Food, Drug, and Cosmetic Act will not apply to the device and state the reasons for making the requirements inapplicable, in accordance with § 860.95;
(2) If classifying the device into class II, establish the special controls for the device and prescribe whether the premarket notification requirement will apply to the device; and
(3) If classifying an implant, or a life-supporting or life-sustaining device, comply with § 860.10(b).