[Title 21 CFR 895]
[Code of Federal Regulations (annual edition) - April 1, 1999 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION,]
[Subchapter H - MEDICAL DEVICES]
[Part 895 - BANNED DEVICES]
[From the U.S. Government Printing Office]
21FOOD AND DRUGS81999-04-011999-04-01falseBANNED DEVICES895PART 895FOOD AND DRUGSFOOD AND DRUG ADMINISTRATION,MEDICAL DEVICES
PART 895--BANNED DEVICES--Table of Contents
Subpart A--General Provisions
Sec.
895.1 Scope.
895.20 General.
895.21 Procedures for banning a device.
895.22 Submission of data and information by the manufacturer,
distributor, or importer.
895.25 Labeling.
895.30 Special effective date.
Subpart B--Listing of Banned Devices
895.101 Prosthetic hair fibers.
Authority: 21 U.S.C. 352, 360f, 360h, 360i, 371.
Source: 44 FR 29221, May 18, 1979, unless otherwise noted.
Subpart A--General Provisions
Sec. 895.1 Scope.
(a) This part describes the procedures by which the Commissioner may
institute proceedings to make a device intended for human use that
presents substantial deception or an unreasonable and substantial risk
of illness or injury a banned device.
(b) This part applies to any ``device'', as defined in section
201(h) of the Federal Food, Drug, and Cosmetic Act (act) that is
intended for human use.
(c) A device that is made a banned device in accordance with this
part is adulterated under section 501(g) of the act. A restricted device
that is banned may also be misbranded under section 502(q) of the act.
(d) Although this part does not cover devices intended for animal
use, the manufacturer, distributor, importer, or any other person(s)
responsible for the labeling of the device that is banned cannot avoid
the ban by relabeling the device for veterinary use. A device that has
been banned from human use but that also has a valid veterinary use may
be marketed for use as a veterinary device only under the following
conditions: The device shall comply with all requirements applicable to
veterinary devices under the Federal Food, Drug, and Cosmetic Act and
this chapter, and the label for the device shall bear the following
statement: ``For Veterinary Use Only. Caution: Federal law prohibits the
distribution of this device for human use.'' A device so labeled,
however, that is determined by the Food and Drug Administration to be
intended for human use, will be considered to be a banned device. In
determining whether such a device is intended for human use, the Food
and Drug Administration will consider, among other things, the ultimate
destination of the device.
Sec. 895.20 General.
The Commissioner may initiate a proceeding to make a device a banned
device whenever the Commissioner finds, on the basis of all available
data and information, that the device presents substantial deception or
an unreasonable and substantial risk of illness or injury that the
Commissioner determines cannot be, or has not been, corrected or
eliminated by labeling or by a change in labeling, or by a change in
advertising if the device is a restricted device.
[44 FR 29221, May 18, 1979, as amended at 57 FR 58405, Dec. 10, 1992]
Sec. 895.21 Procedures for banning a device.
(a) Before initiating a proceeding to make a device a banned device,
the Commissioner shall find that the continued marketing of the device
presents a substantial deception or an unreasonable and substantial risk
of illness or injury.
(1) In determining whether the deception or risk of illness or
injury is substantial, the Commissioner will consider whether the
deception or risk posed by continued marketing of the device, or
continued marketing of the device as presently labeled, is important,
material, or significant in relation to the benefit to the public health
from its continued marketing.
(2) In determining whether a device is deceptive, the Commissioner
will consider whether users of the device may be deceived or otherwise
harmed by the device. The Commissioner is not required to determine that
there was an intent on the part of the manufacturer, distributor,
importer, or any other responsible person(s) to mislead or otherwise
harm users of the device or that
[[Page 491]]
there exists any actual proof of deception of, or injury to, an
individual.
(3) In determining whether a device presents deception or risk of
illness or injury, the Commissioner will consider all available data and
information, including data and information that the Commissioner may
obtain under other provisions of the act, data and information that may
be supplied by the manufacturer, distributor, or importer of the device
under Sec. 895.22, and data and information voluntarily submitted by any
other interested persons.
(b) Before initiating a proceeding to make a device a banned device,
the Commissioner of Food and Drugs (the Commissioner) may consult with
the panel established under section 513 of the act that has expertise
with respect to the type of device under consideration. The consultation
with the panel may occur at a regular or specially scheduled panel
meeting or may be accomplished by correspondence or telephone
conversation with panel members. The Commissioner may request that the
panel submit in writing any advice on the device under consideration.
The Commissioner will record in written memoranda any oral
communications with a panel or its members.
(c) If the Commissioner determines that any substantial deception or
unreasonable and substantial risk of illness or injury or any
unreasonable, direct, and substantial danger to the health of
individuals presented by a device can be corrected or eliminated by
labeling or change in labeling, or change in advertising if the device
is a restricted device, the Commissioner will notify the responsible
person of the required labeling or change in labeling or change in
advertising in accordance with Sec. 895.25. If such required relabeling
or change in advertising is not accomplished in accordance with
Sec. 895.25, the Commissioner may initiate a proceeding to ban the
device in accordance with Sec. 895.21(d) and, when appropriate, may
establish a special effective date in accordance with Sec. 895.30.
(d) If the Commissioner decides to initiate a proceeding to make a
device a banned device, a notice of proposed rulemaking will be
published in the Federal Register to this effect. The notice will
briefly summarize--
(1) The Commissioner's finding under paragraph (a) of this section
that the device presents substantial deception or an unreasonable and
substantial risk of illness or injury, and, when appropriate, the
Commissioner's determination under Sec. 895.30 that the deception or
risk of illness or injury presents an unreasonable, direct, and
substantial danger to the health of individuals;
(2) The reasons why the Commissioner initiated the proceeding;
(3) The evaluation of data and information obtained under other
provisions of the act, submitted by the manufacturer, distributer, or
importer of the device, or voluntarily submitted by any other interested
persons under paragraph (a)(3) of this section, if any;
(4) The consultation with the panel, if any, under paragraph (b) of
this section;
(5) The determination as to whether the deception or risk of illness
or injury or the danger to the health of individuals could be corrected
by labeling or change in labeling, or change in advertising if the
device is a restricted device;
(6) The determination of whether the required labeling or change of
labeling, or change in advertising if the device is a restricted device,
if any, has been made in accordance with paragraph (c) of this section;
(7) The determination as to whether, and the reasons why, the
banning should apply to devices already in commercial distribution or
those already sold to the ultimate user, or both; and
(8) Any other data and information that the Commissioner believes
are pertinent to the proceeding. The notice will afford all interested
persons an opportunity to submit written comments within 30 days after
the date of publication of the proposed regulation. All nonconfidential
information upon which the proposed finding is based, including the
recommendations of the panel, will be available for public review in the
Dockets Management Branch, Food and Drug Administration.
The notice will afford all interested persons an opportunity to submit
written comments and request an informal hearing, as defined in section
201(y) of
[[Page 492]]
the act, before the Food and Drug Administration within 30 days after
the date of publication of the proposed regulation. If a request for an
informal hearing is granted, the hearing will be conducted as a
regulatory hearing under the applicable provisions of part 16 of this
chapter. All nonconfidential information upon which the proposed finding
is based, including the recommendations of the panel, will be available
for public review in the office of the Dockets Management Branch, Food
and Drug Administration.
(e)(1) If, after reviewing the administrative record of the
regulatory hearing before the Food and Drug Administration, if any, the
written comments received on the proposed regulation, and any additional
available data and information, the Commissioner determines to ban a
device, a final regulation to this effect will be published in the
Federal Register. The final regulation will amend subpart B by adding
the name or description of the device, or both, to the list of banned
devices.
(2) If the Commissioner determines not to ban the device, a notice
of withdrawal and termination of rulemaking proceedings and reasons
therefor will be published in the Federal Register.
(f) The effective date of a final regulation to make a device a
banned device, promulgated under paragraph (e) of this section, will be
the date of publication of the final regulation in the Federal Register
unless the Commissioner, for reasons stated, determines that the
effective date should be later than the date of the publication and
specifies that date in the notice. Each such regulation will specify
whether devices already in commercial distribution or sold to the
ultimate user or both are banned.
(g) A regulation promulgated under paragraph (e) of this section is
final agency action, subject to judicial review under section 517 of the
act.
(h) Upon petition of any interested person submitted in accordance
with Sec. 10.30 of this chapter, or as a matter of discretion, the
Commissioner may institute proceedings to amend or revoke a regulation
that made a device a banned device if the Commissioner finds that the
conditions that constituted the basis for the regulation banning the
device are no longer applicable. When appropriate, the procedures in
this section will be employed in such proceedings.
[44 FR 29221, May 18, 1979, as amended at 53 FR 11254, Apr. 6, 1988; 57
FR 58405, Dec. 10, 1992]
Sec. 895.22 Submission of data and information by the manufacturer, distributor, or importer.
(a) A manufacturer, distributor, or importer of a device may be
required to submit to the Food and Drug Administration all relevant and
available data and information to enable the Commissioner to determine
whether the device presents substantial deception, unreasonable and
substantial risk of illness or injury, or unreasonable, direct, and
substantial danger to the health of individuals. The data and
information required by the Commissioner may include scientific or test
data, reports, records, or other information, including data and
information on whether the device is safe and effective for its intended
use or when used as directed, whether the device performs according to
the claims made for the device, and information on adulteration or
misbranding. Any relevant information that is voluntarily submitted will
also be reviewed.
(b) A manufacturer, distributor, or importer of a device required to
submit data and information as provided in paragraph (a) of this section
will be notified in writing by the Food and Drug Administration that
such data and information shall be submitted. The written notification
will advise the manufacturer, distributor, or importer of the device
that the purpose for the request is to enable the Commissioner to
determine whether any of the conditions listed in paragraph (a) of this
section or Sec. 895.30(a)(1) exists with respect to the device such that
a proceeding should be initiated to make the device a banned device.
When the required data and information can be identified by the Food and
Drug Administration at the time of the notification, the agency will
provide such identification to the manufacturer, distributor, or
importer of the device.
(c) The required data and information shall be submitted to the Food
and
[[Page 493]]
Drug Administration no more than 30 days after the date of receipt of
the request, unless the Commissioner determines that the data and
information shall be submitted by some other date and so informs the
manufacturer, distributor, or importer, in which case the data and
information shall be submitted on the date specified by the
Commissioner.
(d) If the data or information submitted to the Food and Drug
Administration is sufficient to persuade the Commissioner that the
deception or risk of illness or injury or the danger to the health of
individuals presented by a device could be corrected or eliminated by
labeling or change in labeling, or change in advertising if the device
is a restricted device, the Commissioner will proceed in accordance with
Sec. 895.25.
(e) If the data or information submitted to the Food and Drug
Administration is insufficient to show that the device does not present
a substantial deception or an unreasonable and substantial risk of
illness or injury, or an unreasonable, direct, and substantial danger to
the health of individuals, or if the manufacturer, distributor, or
importer fails to submit the required information, the Commissioner may
rely upon this insufficiency or failure to submit the required
information in considering whether to initiate a proceeding to make the
device a banned device under Sec. 895.21(d) and, when appropriate, to
establish a special effective date in accordance with Sec. 895.30. The
Commissioner may also initiate other regulatory action as provided in
the act or this chapter.
Sec. 895.25 Labeling.
(a) If the Commissioner determines that the substantial deception or
unreasonable and substantial risk of illness or injury or the
unreasonable, direct, and substantial danger to the health of
individuals presented by a device can be corrected or eliminated by
labeling or a change in labeling, or change in advertising if the device
is a restricted device, the Commissioner will provide written notice to
the manufacturer, distributor, importer, or any other person(s)
responsible for the labeling or advertising of the device specifying:
(1) The deception or risk of illness or injury or the danger to the
health of individuals,
(2) The labeling or change in labeling, or change in advertising if
the device is a restricted device, necessary to correct the deception or
eliminate or reduce such risk or danger, and
(3) The period of time within which the labeling, change in
labeling, or change in advertising must be accomplished.
(b) In specifying the labeling or change in labeling or change in
advertising to correct the deception or to eliminate or reduce the risk
of illness or injury or the danger to the health of individuals, the
Commissioner may require the manufacturer, distributor, importer, or any
other person(s) responsible for the labeling or advertising of the
device to include in labeling for the device, and in advertising if the
device is a restricted device, a statement, notice, or warning. Such
statement, notice, or warning shall be in the manner and form prescribed
by the Commissioner and shall identify the deception or risk of illness
or injury or the unreasonable, direct, and substantial danger to the
health of individuals associated with the device as previously labeled.
Such statement, notice, or warning shall be used in the labeling and
advertising of the device for a time period specified by the
Commissioner on the basis of the degree of deception, risk of illness or
injury, or danger to health; the frequency of sale of the device; the
length of time the device has been on the market; the intended uses of
the device; the method of its use; and any other factors that the
Commissioner considers pertinent.
(c) The Commissioner will allow a manufacturer, distributor,
importer, or any other person(s) responsible for the labeling or
advertising of the device a reasonable time, considering the deception
or risk of illness or injury or the danger to the health of individuals
presented by the device, within which to accomplish the required
labeling, change in labeling, and, if the device is a restricted device,
any change in advertising. The Commissioner may, however, request that
no additional devices be introduced into commerce
[[Page 494]]
until the labeling or change in labeling, or change in advertising is
accomplished by the manufacturer, distributor, importer, or other
person(s) responsible for the labeling or advertising of the device.
(d) If such voluntary action is not taken, the Commissioner may take
action under other sections of the act to prevent the introduction of
the devices into commerce. The Commissioner may consider the failure of
a manufacturer, distributor, importer, or any other person(s)
responsible for the labeling or advertising of the device to accomplish
the required labeling or change in labeling, or change in advertising in
accordance with this section as a basis for initiating a proceeding to
make a device a banned device in accordance with Sec. 895.21(d) and when
appropriate to establish a special effective date in accordance with
Sec. 895.30.
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 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]
[[Page 495]]
Subpart B--Listing of Banned Devices
Sec. 895.101 Prosthetic hair fibers.
Prosthetic hair fibers are devices intended for implantation into
the human scalp to simulate natural hair or conceal baldness. Prosthetic
hair fibers may consist of various materials; for example, synthetic
fibers, such as modacrylic, polyacrylic, and polyester; and natural
fibers, such as processed human hair. Excluded from the banned device
are natural hair transplants, in which a person's hair and its
surrounding tissue are surgically removed from one location on the
person's scalp and then grafted onto another area of the person's scalp.
[48 FR 25136, June 3, 1983]