[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR861.34]

[Page 171-172]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 861--PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT--Table of Contents
 
    Subpart B--Procedures for Performance Standards Development and 
                               Publication
 
Sec. 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

[[Page 172]]

or revoke by regulation a standard established under this part.
    (c) Any petition to amend or revoke a standard shall:
    (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 Sec. 10.30.
    (d) Proceedings to amend or revoke a performance standard shall be 
conducted in accordance with the rulemaking procedures of Sec. 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.