[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: 21CFR895.30]

[Page 550-551]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 895_BANNED DEVICES--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 895.30  Special effective date.

    (a) The Commissioner may declare a proposed regulation under Sec. 
895.21(d) to be effective upon its publication in the

[[Page 551]]

Federal Register and until the effective date of any final action taken 
respecting the regulation if:
    (1) The Commissioner determines, on the basis of all available data 
and information, that the deception or risk of illness or injury 
associated with use of the device that is subject to the regulation 
presents an unreasonable, direct, and substantial danger to the health 
of individuals, and
    (2) Before the date of the publication of such regulation, the 
Commissioner notifies the domestic manufacturer and importer, if any, of 
the device that the regulation is to be made so effective. If necessary, 
the Commissioner may also notify the distributor or any other 
responsible person(s). In addition, the Commissioner will attempt to 
notify any foreign manufacturer when the name and address of the foreign 
manufacturer are readily available.
    (b) This procedure may be used when the Commissioner determines that 
the potential or actual injury involved is a serious one that the 
Commissioner believes will endanger the health of individuals who have 
been, or will be, exposed to the device. In assessing the degree of 
danger, the Commissioner need not find that the danger is immediate, and 
it shall be sufficient for the Commissioner to determine that the danger 
may involve a serious long-term risk.
    (c) If the Commissioner makes a proposed regulation effective in 
accordance with this section, the Commissioner will, as expeditiously as 
possible, give interested persons prompt notice of this action in the 
Federal Register.
    (d) After the hearing, if any, and after considering any written 
comments submitted on the proposal and any additional available 
information and data, the Commissioner will as expeditiously as possible 
either affirm, modify, or revoke the proposed regulation making the 
device a banned device. If the Commissioner decides to affirm or modify 
the proposed regulation to make a device a banned device, the 
Commissioner will amend subpart B by adding the name or description of 
the device, or both, to the list of banned devices. If the Commissioner 
decides to revoke a proposed regulation making a device a banned device, 
a notice of termination of rulemaking proceedings and reasons therefor 
will be published in the Federal Register.
    (e) The Commissioner may declare the special effective date provided 
by this section to be in effect after the publication of a proposed 
regulation under Sec. 895.21(d), if, based on new information, or upon 
reconsideration of previously available information, the Commissioner 
makes the determination and provides the appropriate notices and an 
opportunity for a hearing in accordance with paragraphs (a) and (c) of 
this section.
    (f) Those devices that have been named banned devices under Sec. 
895.30 and that have already been sold to the public may be subject to 
relabeling by the manufacturer, distributor, importer, or any other 
person(s) responsible for the labeling of the device or may be subject 
to the provisions of section 518(a) or (b) of the act.

[44 FR 29221, May 18, 1979, as amended at 57 FR 58405, Dec. 10, 1992]