[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR861.36]

[Page 188]
 
                        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. 861.36  Effective dates.

    (a) A regulation establishing, amending, or revoking a performance 
standard will set forth the date upon which it will take effect. To the 
extent practical, consistent with the public health and safety, such 
effective date will be established so as to minimize economic loss to, 
and disruption or dislocation of, domestic and international trade.
    (b) Except as provided in paragraph (c) of this section, no 
regulation establishing, amending, or revoking a standard may take 
effect before 1 year after the date of its publication unless:
    (1) The Food and Drug Administration determines that an earlier 
effective date is necessary to protect the public health and safety; or
    (2) The standard has been established for a device that, by the 
effective date of the standard, has been reclassified from class III to 
class II.
    (c) The Food and Drug Administration may declare a proposed 
regulation amending a standard effective on publication in the Federal 
Register if it determines that making the regulation so effective is in 
the public interest. A proposed amendment of a performance standard made 
effective upon publication may not prohibit the introduction or delivery 
for introduction into interstate commerce of a device that conforms to 
the standard without the change or changes provided in the proposed 
amendment until the effective date of any final action on the proposal.

[45 FR 7484, Feb. 1, 1980, as amended at 57 FR 58405, Dec. 10, 1992]