21 C.F.R. § 860.134 Procedures for “new devices” under section 513(f) of the act and reclassification of certain devices.
Title 21 - Food and Drugs
(a) Section 513(f)(2) 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 the (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 the [43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992]
Title 21: Food and Drugs
PART 860—MEDICAL DEVICE CLASSIFICATION PROCEDURES
Subpart C—Reclassification
§ 860.134 Procedures for “new devices” under section 513(f) of the act and reclassification of certain devices.
