§ 860.125 - Consultation with panels.

§ 860.125 Consultation with panels.

Cross Reference

Link to an amendment published at 83 FR 64456, Dec. 17, 2018.

(a) When the Commissioner is required chooses to refer a reclassification petition to a classification panel for its recommendation under § 860.134(b), or the Commissioner is required , or chooses, to consult with a panel concerning a reclassification petition , such as submitted under § 860.130, (d) or received in a proceeding under § 860.132, or § 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) 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) 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

post-enactment

postamendments, not substantially equivalent, device

(“new device”), in consulting

, 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.

132

136(a), or received in a proceeding under § 860.

136

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]