21 C.F.R. § 860.125 Consultation with panels.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 860—MEDICAL DEVICE CLASSIFICATION PROCEDURES
Subpart C—Reclassification
§ 860.125 Consultation with panels.
