Title 21

SECTION 861.34

861.34 Amendment or revocation of a standard.

§ 861.34 Amendment or revocation of a standard.

(a) The Food and Drug Administration will provide for periodic evaluation of performance standards to determine whether such standards should be changed to reflect new medical, scientific, or other technological data.

(b) The Food and Drug Administration may, on its own initiative or upon petition of an interested party, amend or revoke by regulation a standard established under this part.

(1) Identify the specific device and standard for which the amendment or revocation is sought; and

(2) Be submitted in accordance with the requirements of § 10.30.

(d) Proceedings to amend or revoke a performance standard shall be conducted in accordance with the rulemaking procedures of § 10.40. In addition, a notice of proposed rulemaking to amend or revoke a standard shall set forth proposed findings with respect to the degree of risk or illness to be eliminated or reduced and the benefit the public will derive from the proposed amendment or revocation.