21 C.F.R. § 860.136 Procedures for transitional products under section 520(l) of the act.
Title 21 - Food and Drugs
(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 the
Title 21: Food and Drugs
PART 860—MEDICAL DEVICE CLASSIFICATION PROCEDURES
Subpart C—Reclassification
§ 860.136 Procedures for transitional products under section 520(l) of the act.
