[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR860.84]

[Page 163-164]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES--Table of Contents
 
                        Subpart B--Classification
 
Sec. 860.84  Classification procedures for ``old devices.''


    (a) This subpart sets forth the procedures for the original 
classification of a device that either was in commercial distribution 
before May 28, 1976, or is substantially equivalent to a device that was 
in commercial distribution before that date. 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 (Sec. 860.3(c)). This 
subpart does not apply to a device that is classified into class III by 
statute under section 513(f) of the 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) through (3) of the act because the device was regarded 
previously as a new drug. In classifying a device under this section, 
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 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 Sec. 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 Sec. 860.7;
    (3) Answers the questions in the classification questionnaire 
applicable to the device being classified;
    (4) Completes a supplemental data sheet for the device;
    (5) 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 Sec. 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,

[[Page 164]]

accompanied by references to the sources containing such data;
    (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 act: 
section 510 (registration, product listing, and premarket notification) 
section 519 (records and reports) and section 520(f) (good manufacturing 
practice regulations) in accordance with Sec. 860.95;
    (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;
    (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, 
accompanied by references to supporting documentation and data 
satisfying the requirements of Sec. 860.7, and an identification of the 
risks to health, if any, presented by the device.
    (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 in the Dockets Management 
Branch's office upon receipt and are available to the public upon 
request.
    (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 act will not 
apply to the device and state the reasons for making the requirements 
inapplicable, in accordance with Sec. 860.95;
    (2) If classifying the device into class II or class III, at the 
discretion of the Commissioner, establish priorities for the application 
to the device of a performance standard or a premarket approval 
requirement;
    (3) If classifying an implant, or life-supporting or life-sustaining 
device, comply with Sec. 860.93(b).

[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992; 
64 FR 404, Jan. 5, 1999]