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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR860]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
 
PART 860MEDICAL DEVICE CLASSIFICATION PROCEDURES
 

Subpart C--Reclassification

Sec. 860.120 General.

(a) Sections 513(e) and (f), 514(b), 515(b), and 520(l) of the act provide for reclassification of a device and prescribe the procedures to be followed to effect reclassification. The purposes of subpart C are to:

(1) Set forth the requirements as to form and content of petitions for reclassification;

(2) Describe the circumstances in which each of the five statutory reclassification provisions applies; and

(3) Explain the procedure for reclassification prescribed in the five statutory reclassification provisions.

(b) The criteria for determining the proper class for a device are set forth in 860.3(c). The reclassification of any device within a generic type of device causes the reclassification of all substantially equivalent devices within that generic type. Accordingly, a petition for the reclassification of a specific device will be considered a petition for reclassification of all substantially equivalent devices within the same generic type.

(c) Any interested person may submit a petition for reclassification under section 513(e), 514(b), or 515(b). A manufacturer or importer may submit a petition for reclassification under section 513(f) or 520(l). The Commissioner may initiate the reclassification of a device classified into class III under sections 513(f) and 520(l) of the act.

[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992]

Sec. 860.123 Reclassification petition: Content and form.

(a) Unless otherwise provided in writing by the Commissioner, any petition for reclassification of a device, regardless of the section of the act under which it is filed, shall include the following:

(1) A specification of the type of device for which reclassification is requested;

(2) A statement of the action requested by the petitioner, e.g., "It is requested that _ device(s) be reclassified from class III to a class II";

(3) A completed supplemental data sheet applicable to the device for which reclassification is requested;

(4) A completed classification questionnaire applicable to the device for which reclassification is requested;

(5) A statement of the basis for disagreement with the present classification status of the device;

(6) A full statement of the reasons, together with supporting data satisfying the requirements of 860.7, why the device should not be classified into its present classification and how the proposed classification will provide reasonable assurance of the safety and effectiveness of the device;

(7) Representative data and information known by the petitioner that are unfavorable to the petitioner's position;

(8) If the petition is based upon new information under section 513(e), 514(b), or 515(b) of the act, a summary of the new information;

(9) Copies of source documents from which new information used to support the petition has been obtained (attached as appendices to the petition).

(10) A financial certification or disclosure statement or both as required by part 54 of this chapter.

(b) Each petition submitted pursuant to this section shall be:

(1) For devices regulated by the Center for Devices and Radiological Health, addressed to the Food and Drug Administration, Center for Devices and Radiological Health, Regulations Staff, 10903 New Hampshire Ave., Bldg. 66, rm. 4425, Silver Spring, MD 20993-0002; for devices regulated by the Center for Biologics Evaluation and Research, addressed to the Document Control Center (HFM-99), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448; for devices regulated by the Center for Drug Evaluation and Research, addressed to the Central Document Control Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266, as applicable.

(2) Marked clearly with the section of the act under which the petition is being submitted, i.e., "513(e)," "513(f)," "514(b)," "515(b)," or "520(l) Petition";

(3) Bound in a volume or volumes, where necessary; and

(4) Submitted in an original and two copies.

[43 FR 32993, July 28, 1978, as amended at 49 FR 14505, Apr. 12, 1984; 53 FR 11253, Apr. 6, 1988; 55 FR 11169, Mar. 27, 1990; 63 FR 5254, Feb. 2, 1998; 65 FR 17137, Mar. 31, 2000; 73 FR 49942, Aug. 25, 2008; 75 FR 20916, Apr. 22, 2010]

Sec. 860.125 Consultation with panels.

(a) When the Commissioner is required to refer a reclassification petition to a classification panel for its recommendation under 860.134, or is required, or chooses, to consult with a panel concerning a reclassification petition, such as under 860.130, 860.132, or 860.136, the Commissioner will distribute a copy of the petition, or its relevant portions, to each panel member and will consult with the panel in one of the following ways:

(1) Consultation by telephone with at least a majority of current voting panel members and, when possible, nonvoting panel members;

(2) Consultation by mail with at least a majority of current voting panel members and, when possible, nonvoting panel members; and

(3) Discussion at a panel meeting.

(b) The method of consultation chosen by the Commissioner will depend upon the importance and complexity of the subject matter involved and the time available for action. When time and circumstances permit, the Commissioner will consult with a panel through discussion at a panel meeting.

(c) When a petition is submitted under 860.134 for a post-enactment, not substantially equivalent device ("new device"), in consulting with the panel the Commissioner will obtain a recommendation that includes the information described in 860.84(d). In consulting with a panel about a petition submitted under 860.130, 860.132, or 860.136, the Commissioner may or may not obtain a formal recommendation.

Sec. 860.130 General procedures under section 513(e) of the act.

(a) Section 513(e) of the act applies to reclassification proceedings under the act based upon new information.

(b) A proceeding to reclassify a device under section 513(e) may be initiated:

(1) On the initiative of the Commissioner alone;

(2) On the initiative of the Commissioner in response to a request for change in classification based upon new information, under section 514(b) or 515(b) of the act (see 860.132); or

(3) In response to the petition of an interested person, based upon new information, filed in accordance with 860.123.

(c) By regulation promulgated under this section, the Commissioner may change the classification from class III into:

(1) Class II if the Commissioner determines that special controls in addition to general controls would provide reasonable assurance of the safety and effectiveness of the device and there is sufficient information to establish special controls to provide assurance; or

(2) Class I if the Commissioner determines that general controls would provide reasonable assurance of the safety and effectiveness of the device.

(d) The rulemaking procedures in 10.40 of this chapter apply to proceedings to reclassify a device under section 513(e), except that the Commissioner may secure a recommendation with respect to a proposed reclassification from the classification panel to which the device was last referred. The panel will consider a proposed reclassification submitted to it by the Commissioner in accordance with the consultation procedures of 860.125. Any recommendation submitted to the Commissioner by the panel will be published in theFederal Registerwhen the Commissioner promulgates a regulation under this section.

(e) Within 180 days after the filing of a petition for reclassification under this section, the Commissioner, by order published in theFederal Register,will either deny the petition or give notice of his intent to initiate a change in the classification of the device.

(f) If a device is reclassified under this section, the regulation effecting the reclassification may revoke any special control or premarket approval requirement that previously applied to the device but that is no longer applicable because of the change in classification.

(g) A regulation under this section changing the classification of a device from class III to class II may provide that such classification will not take effect until the effective date of a special control for the device established under section 514 of the act.

[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992]

Sec. 860.132 Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the act.

(a) Sections 514(b) and 515(b) of the act require the Commissioner to provide, by notice in theFederal Register,an opportunity for interested parties to request a change in the classification of a device based upon new information relevant to its classification when the Commissioner initiates a proceeding either to develop a performance standard for the device if in class II, or to promulgate a regulation requiring premarket approval for the device if in class III. In either case, if the Commissioner agrees that the new information warrants a change in classification, the Commissioner will publish in theFederal Registernotice of the Commissioner's intent to initiate a proceeding under section 513(e) of the act and 860.130 to effect such a change.

(b) The procedures for effecting a change in classification under sections 514(b) and 515(b) of the act are as follows:

(1) Within 15 days after publication of the Commissioner's notice referred to in paragraph (a) of this section, an interested person files a petition for reclassification in accordance with 860.123.

(2) The Commissioner consults with the appropriate classification panel with regard to the petition in accordance with 860.125.

(3) Within 60 days after publication of the notice referred to in paragraph (a) of this section, the Commissioner, by order published in theFederal Register,either denies the petition or gives notice of his intent to initiate a change in classification in accordance with 860.130.

Sec. 860.134 Procedures for "new devices" under section 513(f) of the act and reclassification of certain devices.

(a) Section 513(f)(3) of the act applies to proceedings for reclassification of a device currently in class III by operation of section 513(f)(1) of the act. This category includes any device that is to be first introduced or delivered for introduction into interstate commerce for commercial distribution after May 28, 1976, unless:

(1) It is substantially equivalent to another device that was in commercial distribution before that date and had not been regulated before that date as a new drug; or

(2) It is substantially equivalent to another device that was not in commercial distribution before such date but which has been classified into class I or class II; or

(3) The Commissioner has classified the device into class I or class II in response to a petition for reclassification under this section.

The Commissioner determines whether a device is "substantially equivalent" for purposes of the application of this section. If a manufacturer or importer believes that a device is not "substantially equivalent" but that it should not be in class III under the criteria in 860.3(c), the manufacturer or importer may petition for reclassification under this section. A manufacturer or importer who believes that a device is "substantially equivalent" and wishes to proceed to market the device shall submit a premarket notification in accordance with part 807 of this chapter. After considering a premarket notification, the Commissioner will determine whether the device is "substantially equivalent" and will notify the manufacturer or importer of such determination in accordance with part 807 of this chapter.

(b) The procedures for effecting reclassification under section 513(f) of the act are as follows:

(1) The manufacturer or importer of the device petitions for reclassification of the device in accordance with 860.123.

(2) Within 30 days after the petition is filed, the Commissioner notifies the petitioner of any deficiencies in the petition that prevent the Commissioner from making a decision on it and allows the petitioner to supplement a deficient petition. Within 30 days after any supplemental material is received, the Commissioner notifies the petitioner whether the petition, as supplemented, is adequate for review.

(3) After determining that the petition contains no deficiencies precluding a decision on it, the Commissioner may for good cause shown refer the petition to the appropriate classification panel for its review and recommendation whether to approve or deny the petition.

(4) Within 90 days after the date the petition is referred to the panel, following the review procedures set forth in 860.84(c) for the original classification of an "old" device, the panel submits to the Commissioner its recommendation containing the information set forth in 860.84(d). A panel recommendation is regarded as preliminary until the Commissioner has reviewed it, discussed it with the panel, if appropriate, and developed a proposed reclassification order. Preliminary panel recommendations are filed in the Division of Dockets Management upon receipt and are available to the public upon request.

(5) The panel recommendation is published in theFederal Registeras soon as practicable and interested persons are provided an opportunity to comment on the recommendation.

(6) Within 90 days after the panel's recommendation is received (and no more than 210 days after the date the petition was filed), the Commissioner denies or approves the petition by order in the form of a letter to the petitioner. If the Commissioner approves the petition, the order will classify the device into class I or class II in accordance with the criteria set forth in 860.3(c) and subject to the applicable requirements of 860.93, relating to the classification of implants, life-supporting or life-sustaining devices, and 860.95, relating to exemptions from certain requirements of the act.

(7) Within a reasonable time after issuance of an order under this section, the Commissioner announces the order by notice published in theFederal Register.

[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992; 73 FR 34860, June 19, 2008]

Sec. 860.136 Procedures for transitional products under section 520(l) of the act.

(a) Section 520(l)(2) of the act applies to reclassification proceedings initiated by a manufacturer or importer for reclassification of a device currently in class III by operation of section 520(l)(1) of the act. This section applies only to devices that the Food and Drug Administration regarded as "new drugs" before May 28, 1976.

(b) The procedures for effecting reclassification under section 520(l) are as follows:

(1) The manufacturer or importer of the device files a petition for reclassification of the device in accordance with 860.123.

(2) Within 30 days after the petition is filed, the Commissioner notifies the petitioner of any deficiencies in the petition that prevent the Commissioner from making a decision on it, allowing the petitioner to supplement a deficient petition. Within 30 days after any supplemental material is received, the Commissioner notifies the petitioner whether the petition, as supplemented, is adequate for review.

(3) The Commissioner provides the petitioner an opportunity for a regulatory hearing conducted in accordance with part 16 of this chapter.

(4) The Commissioner consults with the appropriate classification panel with regard to the petition in accordance with 860.125.

(5) Within 180 days after the petition is filed (where the Commissioner has determined it to be adequate for review), the Commissioner, by order in the form of a letter to the petitioner, either denies the petition or classifies the device into class I or class II in accordance with the criteria set forth in 860.3(c).

(6) Within a reasonable time after issuance of an order under this section, the Commissioner announces the order by notice published in theFederal Register.

Authority: 21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374.
Source: 43 FR 32993, July 28, 1978, unless otherwise noted.

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