Code of Federal Regulations Title 21. Food and Drugs § 21.861.38 Standards advisory committees

(a) The Food and Drug Administration will establish advisory committees to which proposed regulations may be referred, and these committees shall consider such referrals in accordance with this section and part 14 of this chapter. Such advisory committees, which may not be classification panels, shall be considered ad hoc advisory committees. Their members shall be selected in accordance with §§ 14.82 and 14.84, except that no member may be a regular full-time FDA employee. Each advisory committee established under this section shall include as nonvoting members a representative of consumer interests and a representative of interests of the device manufacturing industry.

(b) A proposed regulation to establish, amend, or revoke a performance standard shall be referred to an advisory committee for a report and recommendation with respect to any matter involved in the proposed regulation which requires the exercise of scientific judgment if:

(c) When a proposed regulation is referred to an advisory committee, the Food and Drug Administration will furnish the committee with the data and information upon which the proposed regulation is based. After independently reviewing the materials furnished by the Food and Drug Administration and any other available data and information, the advisory committee shall, within 60 days of the referral, submit a report and recommendation on the proposed regulation, together with all underlying data and information and a statement of the reason or basis for the recommendation. A copy of the report and recommendation will be publicly displayed in the office of the Division of Dockets Management, Food and Drug Administration.

(d) Where appropriate, each proposed regulation establishing a standard published in the Federal Register will include a call for nominations to the advisory committee for that particular standard.