CFR - Code of Federal Regulations Title 21

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[Code of Federal Regulations]

[Title 21, Volume 8]

[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 Federal Food, Drug, and Cosmetic 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 devices within that generic type. Accordingly, a petition for the reclassification of a specific device will be considered a petition for reclassification of all 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) of the Federal Food, Drug, and Cosmetic Act. A manufacturer or importer may submit a petition for reclassification under section 513(f) or 520(l ) of the Federal Food, Drug, and Cosmetic Act. The Commissioner may initiate the reclassification of a device under the following sections of the Federal Food, Drug, and Cosmetic Act:

(1) Section 513(e) (for a classified device other than a device classified into class III under section 513(f)(1) or 520(l )(1) of the Federal Food, Drug, and Cosmetic Act);

(2) Section 513(f)(3) (for a device classified into class III under section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act); or

(3) Section 520(l )(2) (for a device classified into class III under section 520(l )(1) of the Federal Food, Drug, and Cosmetic Act).

[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992; 83 FR 64456, Dec. 17, 2018]

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 Federal Food, Drug, and Cosmetic 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 statement of the basis for disagreement with the present classification status of the device;

(4) 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;

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

(6) If the petition is based upon new information under section 513(e), 514(b), or 515(b) of the Federal Food, Drug, and Cosmetic Act, a summary of the new information;

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

(8) 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, Office of Policy Staff, 10903 New Hampshire Ave., Bldg. 66, Rm. 5445, Silver Spring, MD 20993-0002; for devices regulated by the Center for Biologics Evaluation and Research, addressed to the Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002; for devices regulated by the Center for Drug Evaluation and Research, addressed to the Food and Drug Administration, Center for Drug Evaluation and Research, Central Document Control Room, 5901-B Ammendale Rd., Beltsville, MD 20705-1266, as applicable.

(2) Marked clearly with the section of the Federal Food, Drug, and Cosmetic Act under which the petition is being submitted, i.e., "513(e)," "513(f)(3)," "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; 79 FR 77388, Dec. 24, 2014; 82 FR 39535, Aug. 21, 2017; 83 FR 64456, Dec. 17, 2018; 85 FR 18443, Apr. 2, 2020]

Sec. 860.125 Consultation with panels.

(a) When the Commissioner chooses to refer a reclassification petition to a classification panel for its recommendation under § 860.134(b), or the Commissioner is required to consult with a panel concerning a reclassification petition submitted under § 860.130(d) or received in a proceeding under § 860.133(b), or the Commissioner chooses to consult with a panel with regard to the reclassification of a device initiated by the Commissioner under § 860.134(c) or § 860.136, the Commissioner will distribute a copy of the petition, or its relevant portions, if applicable, 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 in a telephone or video conference call; or

(2) 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) The Commissioner will consult with a classification panel prior to changing the classification of a device in a proceeding under section 513(e) of the Federal Food, Drug, and Cosmetic Act and § 860.130 upon the Commissioner's own initiative or upon petition of an interested person, and in the latter case, the Commissioner will distribute a copy of the petition, or its relevant portions, to each panel member.

(d) When a petition is submitted under § 860.134 for a postamendments, not substantially equivalent, device, if the Commissioner chooses to consult 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(d), § 860.136(a), or received in a proceeding under § 860.133(b), the Commissioner may or may not obtain a formal recommendation.

[43 FR 32993, July 28, 1978, as amended at 83 FR 64456, Dec. 17, 2018]

Sec. 860.130 General procedures under section 513(e) of the Federal Food, Drug, and Cosmetic Act.

(a) Section 513(e) of the Federal Food, Drug, and Cosmetic Act applies to reclassification proceedings under the Federal Food, Drug, and Cosmetic 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 Federal Food, Drug, and Cosmetic 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.

(1) Class I or class II to class III if the Commissioner determines that the device meets the criteria set forth in § 860.3(c)(3) for a class III device; or

(2) Class III or class I to class II if the Commissioner determines that the device meets the criteria set forth in § 860.3(c)(2) for a class II device; or

(3) Class III or class II to class I if the Commissioner determines that the device meets the criteria set forth in § 860.3(c)(1) for a class I device.

(d)(1) The Commissioner shall consult with a classification panel and may secure a recommendation with respect to reclassification of a device from a classification panel. The panel will consider reclassification in accordance with the consultation procedures of § 860.125. A recommendation submitted to the Commissioner by the panel will be published in the Federal Register when the Commissioner publishes an administrative order under this section.

(2) The Commissioner may change the classification of a device by administrative order published in the Federal Register following publication of a proposed reclassification order in the Federal Register, a meeting of a device classification panel described in section 513(b) of the Federal Food, Drug, and Cosmetic Act, and consideration of comments to a public docket.

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

(f) If a device is reclassified under this section, the administrative order 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) An administrative order under this section changing the classification of a device to class II may provide that such reclassification will not take effect until the effective date of a performance standard for the device established under section 514 of the Federal Food, Drug, and Cosmetic Act or other special controls established under the order. An order under this section changing the classification of a device to class II may also establish the special controls necessary to provide reasonable assurance of the safety and effectiveness of the device.

[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992; 83 FR 64456, Dec. 17, 2018]

Sec. 860.132 Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the Federal Food, Drug, and Cosmetic Act.

(a) Sections 514(b) and 515(b) of the Federal Food, Drug, and Cosmetic Act require the Commissioner to provide, by notice in the Federal Register, an opportunity for interested parties to petition to change the classification of a device based upon new information relevant to its classification when the Commissioner initiates a proceeding to develop a performance standard for the device if in class II or to issue an order requiring premarket approval for the device if in class III.

(b) If the Commissioner agrees that the new information submitted in response to a proposed order to require premarket approval of a device issued under section 515(b) of the Federal Food, Drug, and Cosmetic Act warrants a change in classification, the Commissioner shall follow the administrative order procedures under section 513(e) of the Federal Food, Drug, and Cosmetic Act and § 860.130 to effect such a change.

(c) If the Commissioner does not agree that the new information submitted in response to a proposed order to require premarket approval of a device issued under section 515(b) of the Federal Food, Drug, and Cosmetic Act warrants a change in classification, the Commissioner will deny the petition.

(d) The procedures under section 514(b) of the Federal Food, Drug, and Cosmetic Act are as follows:

(1) Within 30 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 either denies the petition or gives notice of the intent to initiate a change in classification in accordance with § 860.130.

[43 FR 32993, July 28, 1978, as amended at 83 FR 64457, Dec. 17, 2018]

Sec. 860.133 Procedures when the Commissioner initiates a proceeding to require premarket approval under section 515(b) of the Federal Food, Drug, and Cosmetic Act.

(a) Section 515(b) of the Federal Food, Drug, and Cosmetic Act applies to proceedings to require premarket approval for a class III preamendments device.

(b) The Commissioner may require premarket approval for a class III preamendments device by administrative order published in the Federal Register following publication of a proposed order in the Federal Register, a meeting of a device classification panel described in section 513(b) of the Federal Food, Drug, and Cosmetic Act, and consideration of comments from all affected stakeholders, including patients, payors, and providers. The panel will consider reclassification petitions received in the proceeding in accordance with section 513(e) of the Federal Food, Drug, and Cosmetic and the applicable consultation procedures in § 860.125. A recommendation submitted to the Commissioner by the panel will be published in the Federal Register when the Commissioner publishes an administrative order under this section.

[83 FR 64457, Dec. 17, 2018]

Sec. 860.134 Procedures for reclassification of "postamendments devices" under section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act.

(a) Section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act applies to proceedings for reclassification of a device currently in class III by operation of section 513(f)(1) of the Federal Food, Drug, and Cosmetic 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; or

(4) The device is classified under a request for De Novo classification under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act.

(b) The procedures for effecting reclassification under section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act when initiated by a manufacturer or importer 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 a "preamendments 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 at Dockets Management Staff upon receipt and are available to the public and posted at https://www.regulations.gov.

(5) The panel recommendation is published in the Federal Register as 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 § 860.10, relating to the classification of implants and life-supporting or life-sustaining devices, and § 860.15, relating to exemptions from certain requirements of the Federal Food, Drug, and Cosmetic Act.

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

(c) By administrative order published under section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act, the Commissioner may, on the Commissioner's own initiative, change the classification from class III under section 513(f)(1) either to class II, if the Commissioner determines that special controls in addition to general controls are necessary and sufficient to provide reasonable assurance of the safety and effectiveness of the device and there is sufficient information to establish special controls to provide such assurance, or to class I if the Commissioner determines that general controls alone would provide reasonable assurance of the safety and effectiveness of the device. The procedures for the reclassification proceeding under this paragraph (c) are as follows:

(1) The Commissioner publishes a proposed reclassification order in the Federal Register seeking comment on the proposed reclassification.

(2) The Commissioner may consult with the appropriate classification panel with respect to the reclassification of the device. The panel will consider reclassification in accordance with the consultation procedures of § 860.125.

(3) Following consideration of comments to a public docket and any panel recommendations or comments, the Commissioner may change the classification of a device by final administrative order published in the Federal Register.

(d) An administrative order under this section changing the classification of a device from class III to class II may establish the special controls necessary to provide reasonable assurance of the safety and effectiveness of the device.

[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992; 73 FR 34860, June 19, 2008; 83 FR 64457, Dec. 17, 2018]

Sec. 860.136 Procedures for transitional products under section 520(l) of the Federal Food, Drug, and Cosmetic Act.

(a) Section 520(l )(2) of the Federal Food, Drug, and Cosmetic Act applies to reclassification proceedings initiated by the Commissioner or in response to a request by a manufacturer or importer for reclassification of a device currently in class III by operation of section 520(l )(1). 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 ) of the Federal Food, Drug, and Cosmetic Act when initiated by a manufacturer or importer 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 consults with the appropriate classification panel with regard to the petition in accordance with § 860.125.

(4) 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).

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

(c) By administrative order, the Commissioner may, on the Commissioner's own initiative, change the classification from class III under section 520(l ) of the Federal Food, Drug, and Cosmetic Act either to class II, if the Commissioner determines that special controls in addition to general controls are necessary and sufficient to provide reasonable assurance of the safety and effectiveness of the device and there is sufficient information to establish special controls to provide such assurance, or to class I if the Commissioner determines that general controls alone would provide reasonable assurance of the safety and effectiveness of the device. The procedures for the reclassification proceeding under this paragraph (c) are as follows:

(1) The Commissioner publishes a proposed reclassification order in the Federal Register seeking comment on the proposed reclassification.

[43 FR 32993, July 28, 1978, as amended at 83 FR 64458, Dec. 17, 2018]

Authority: 21 U.S.C. 321(h), 353(g), 360c, 360d, 360e, 360i, 360j, 371, 374.
Source: 43 FR 32993, July 28, 1978, unless otherwise noted.

CFR - Code of Federal Regulations Title 21

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