Procedures for reclassification of “postamendments devices” under section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act.
21 C.F.R. § 860.134
in effectEffective: 2024-07-01(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.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026