21 U.S.C. § 360c : US Code - Section 360C: Classification of devices intended for human use

Search 21 U.S.C. § 360c : US Code - Section 360C: Classification of devices intended for human use

(a) Classes of devices
(1) There are established the following classes of devices
intended for human use:
(A) Class I, General Controls. -
(i) A device for which the controls authorized by or under
section 351, 352, 360, 360f, 360h, 360i, or 360j of this title
or any combination of such sections are sufficient to provide
reasonable assurance of the safety and effectiveness of the
device.
(ii) A device for which insufficient information exists to
determine that the controls referred to in clause (i) are
sufficient to provide reasonable assurance of the safety and
effectiveness of the device or to establish special controls to
provide such assurance, but because it -
(I) is not purported or represented to be for a use in
supporting or sustaining human life or for a use which is of
substantial importance in preventing impairment of human
health, and
(II) does not present a potential unreasonable risk of
illness or injury,
is to be regulated by the controls referred to in clause (i).
(B) Class II, Special Controls. - A device which cannot be
classified as a class I device because the general controls by
themselves are insufficient to provide reasonable assurance of
the safety and effectiveness of the device, and for which there
is sufficient information to establish special controls to
provide such assurance, including the promulgation of performance
standards, postmarket surveillance, patient registries,
development and dissemination of guidelines (including guidelines
for the submission of clinical data in premarket notification
submissions in accordance with section 360(k) of this title),
recommendations, and other appropriate actions as the Secretary
deems necessary to provide such assurance. For a device that is
purported or represented to be for a use in supporting or
sustaining human life, the Secretary shall examine and identify
the special controls, if any, that are necessary to provide
adequate assurance of safety and effectiveness and describe how
such controls provide such assurance.
(C) Class III, Premarket Approval. - A device which because -
(i) it (I) cannot be classified as a class I device because
insufficient information exists to determine that the
application of general controls are sufficient to provide
reasonable assurance of the safety and effectiveness of the
device, and (II) cannot be classified as a class II device
because insufficient information exists to determine that the
special controls described in subparagraph (B) would provide
reasonable assurance of its safety and effectiveness, and
(ii)(I) is purported or represented to be for a use in
supporting or sustaining human life or for a use which is of
substantial importance in preventing impairment of human
health, or
(II) presents a potential unreasonable risk of illness or
injury,
is to be subject, in accordance with section 360e of this title,
to premarket approval to provide reasonable assurance of its
safety and effectiveness.
If there is not sufficient information to establish a performance
standard for a device to provide reasonable assurance of its safety
and effectiveness, the Secretary may conduct such activities as may
be necessary to develop or obtain such information.
(2) For purposes of this section and sections 360d and 360e of
this title, the safety and effectiveness of a device are to be
determined -
(A) with respect to the persons for whose use the device is
represented or intended,
(B) with respect to the conditions of use prescribed,
recommended, or suggested in the labeling of the device, and
(C) weighing any probable benefit to health from the use of the
device against any probable risk of injury or illness from such
use.
(3)(A) Except as authorized by subparagraph (B), the
effectiveness of a device is, for purposes of this section and
sections 360d and 360e of this title, to be determined, in
accordance with regulations promulgated by the Secretary, on the
basis of well-controlled investigations, including 1 or more
clinical investigations where appropriate, by experts qualified by
training and experience to evaluate the effectiveness of the
device, from which investigations it can fairly and responsibly be
concluded by qualified experts that the device will have the effect
it purports or is represented to have under the conditions of use
prescribed, recommended, or suggested in the labeling of the
device.
(B) If the Secretary determines that there exists valid
scientific evidence (other than evidence derived from
investigations described in subparagraph (A)) -
(i) which is sufficient to determine the effectiveness of a
device, and
(ii) from which it can fairly and responsibly be concluded by
qualified experts that the device will have the effect it
purports or is represented to have under the conditions of use
prescribed, recommended, or suggested in the labeling of the
device,
then, for purposes of this section and sections 360d and 360e of
this title, the Secretary may authorize the effectiveness of the
device to be determined on the basis of such evidence.
(C) In making a determination of a reasonable assurance of the
effectiveness of a device for which an application under section
360e of this title has been submitted, the Secretary shall consider
whether the extent of data that otherwise would be required for
approval of the application with respect to effectiveness can be
reduced through reliance on postmarket controls.
(D)(i) The Secretary, upon the written request of any person
intending to submit an application under section 360e of this
title, shall meet with such person to determine the type of valid
scientific evidence (within the meaning of subparagraphs (A) and
(B)) that will be necessary to demonstrate for purposes of approval
of an application the effectiveness of a device for the conditions
of use proposed by such person. The written request shall include a
detailed description of the device, a detailed description of the
proposed conditions of use of the device, a proposed plan for
determining whether there is a reasonable assurance of
effectiveness, and, if available, information regarding the
expected performance from the device. Within 30 days after such
meeting, the Secretary shall specify in writing the type of valid
scientific evidence that will provide a reasonable assurance that a
device is effective under the conditions of use proposed by such
person.
(ii) Any clinical data, including one or more well-controlled
investigations, specified in writing by the Secretary for
demonstrating a reasonable assurance of device effectiveness shall
be specified as result of a determination by the Secretary that
such data are necessary to establish device effectiveness. The
Secretary shall consider, in consultation with the applicant, the
least burdensome appropriate means of evaluating device
effectiveness that would have a reasonable likelihood of resulting
in approval.
(iii) The determination of the Secretary with respect to the
specification of valid scientific evidence under clauses (i) and
(ii) shall be binding upon the Secretary, unless such determination
by the Secretary could be contrary to the public health.
(b) Classification panels
(1) For purposes of -
(A) determining which devices intended for human use should be
subject to the requirements of general controls, performance
standards, or premarket approval, and
(B) providing notice to the manufacturers and importers of such
devices to enable them to prepare for the application of such
requirements to devices manufactured or imported by them,
the Secretary shall classify all such devices (other than devices
classified by subsection (f) of this section) into the classes
established by subsection (a) of this section. For the purpose of
securing recommendations with respect to the classification of
devices, the Secretary shall establish panels of experts or use
panels of experts established before May 28, 1976, or both. Section
14 of the Federal Advisory Committee Act shall not apply to the
duration of a panel established under this paragraph.
(2) The Secretary shall appoint to each panel established under
paragraph (1) persons who are qualified by training and experience
to evaluate the safety and effectiveness of the devices to be
referred to the panel and who, to the extent feasible, possess
skill in the use of, or experience in the development, manufacture,
or utilization of, such devices. The Secretary shall make
appointments to each panel so that each panel shall consist of
members with adequately diversified expertise in such fields as
clinical and administrative medicine, engineering, biological and
physical sciences, and other related professions. In addition, each
panel shall include as nonvoting members a representative of
consumer interests and a representative of interests of the device
manufacturing industry. Scientific, trade, and consumer
organizations shall be afforded an opportunity to nominate
individuals for appointment to the panels. No individual who is in
the regular full-time employ of the United States and engaged in
the administration of this chapter may be a member of any panel.
The Secretary shall designate one of the members of each panel to
serve as chairman thereof.
(3) Panel members (other than officers or employees of the United
States), while attending meetings or conferences of a panel or
otherwise engaged in its business, shall be entitled to receive
compensation at rates to be fixed by the Secretary, but not at
rates exceeding the daily equivalent of the rate in effect for
grade GS-18 of the General Schedule, for each day so engaged,
including traveltime; and while so serving away from their homes or
regular places of business each member may be allowed travel
expenses (including per diem in lieu of subsistence) as authorized
by section 5703 of title 5, for persons in the Government service
employed intermittently.
(4) The Secretary shall furnish each panel with adequate clerical
and other necessary assistance.
(5) Classification panels covering each type of device shall be
scheduled to meet at such times as may be appropriate for the
Secretary to meet applicable statutory deadlines.
(6)(A) Any person whose device is specifically the subject of
review by a classification panel shall have -
(i) the same access to data and information submitted to a
classification panel (except for data and information that are
not available for public disclosure under section 552 of title 5)
as the Secretary;
(ii) the opportunity to submit, for review by a classification
panel, information that is based on the data or information
provided in the application submitted under section 360e of this
title by the person, which information shall be submitted to the
Secretary for prompt transmittal to the classification panel; and
(iii) the same opportunity as the Secretary to participate in
meetings of the panel.
(B) Any meetings of a classification panel shall provide adequate
time for initial presentations and for response to any differing
views by persons whose devices are specifically the subject of a
classification panel review, and shall encourage free and open
participation by all interested persons.
(7) After receiving from a classification panel the conclusions
and recommendations of the panel on a matter that the panel has
reviewed, the Secretary shall review the conclusions and
recommendations, shall make a final decision on the matter in
accordance with section 360e(d)(2) of this title, and shall notify
the affected persons of the decision in writing and, if the
decision differs from the conclusions and recommendations of the
panel, shall include the reasons for the difference.
(8) A classification panel under this subsection shall not be
subject to the annual chartering and annual report requirements of
the Federal Advisory Committee Act.
(c) Classification panel organization and operation
(1) The Secretary shall organize the panels according to the
various fields of clinical medicine and fundamental sciences in
which devices intended for human use are used. The Secretary shall
refer a device to be classified under this section to an
appropriate panel established or authorized to be used under
subsection (b) of this section for its review and for its
recommendation respecting the classification of the device. The
Secretary shall by regulation prescribe the procedure to be
followed by the panels in making their reviews and recommendations.
In making their reviews of devices, the panels, to the maximum
extent practicable, shall provide an opportunity for interested
persons to submit data and views on the classification of the
devices.
(2)(A) Upon completion of a panel's review of a device referred
to it under paragraph (1), the panel shall, subject to
subparagraphs (B) and (C), submit to the Secretary its
recommendation for the classification of the device. Any such
recommendation shall (i) contain (I) a summary of the reasons for
the recommendation, (II) a summary of the data upon which the
recommendation is based, and (III) an identification of the risks
to health (if any) presented by the device with respect to which
the recommendation is made, and (ii) to the extent practicable,
include a recommendation for the assignment of a priority for the
application of the requirements of section 360d or 360e of this
title to a device recommended to be classified in class II or class
III.
(B) A recommendation of a panel for the classification of a
device in class I shall include a recommendation as to whether the
device should be exempted from the requirements of section 360,
360i, or 360j(f) of this title.
(C) In the case of a device which has been referred under
paragraph (1) to a panel, and which -
(i) is intended to be implanted in the human body or is
purported or represented to be for a use in supporting or
sustaining human life, and
(ii)(I) has been introduced or delivered for introduction into
interstate commerce for commercial distribution before May 28,
1976, or
(II) is within a type of device which was so introduced or
delivered before such date and is substantially equivalent to
another device within that type,
such panel shall recommend to the Secretary that the device be
classified in class III unless the panel determines that
classification of the device in such class is not necessary to
provide reasonable assurance of its safety and effectiveness. If a
panel does not recommend that such a device be classified in class
III, it shall in its recommendation to the Secretary for the
classification of the device set forth the reasons for not
recommending classification of the device in such class.
(3) The panels shall submit to the Secretary within one year of
the date funds are first appropriated for the implementation of
this section their recommendations respecting all devices of a type
introduced or delivered for introduction into interstate commerce
for commercial distribution before May 28, 1976.
(d) Panel recommendation; publication; priorities
(1) Upon receipt of a recommendation from a panel respecting a
device, the Secretary shall publish in the Federal Register the
panel's recommendation and a proposed regulation classifying such
device and shall provide interested persons an opportunity to
submit comments on such recommendation and the proposed regulation.
After reviewing such comments, the Secretary shall, subject to
paragraph (2), by regulation classify such device.
(2)(A) A regulation under paragraph (1) classifying a device in
class I shall prescribe which, if any, of the requirements of
section 360, 360i, or 360j(f) of this title shall not apply to the
device. A regulation which makes a requirement of section 360,
360i, or 360j(f) of this title inapplicable to a device shall be
accompanied by a statement of the reasons of the Secretary for
making such requirement inapplicable.
(B) A device described in subsection (c)(2)(C) of this section
shall be classified in class III unless the Secretary determines
that classification of the device in such class is not necessary to
provide reasonable assurance of its safety and effectiveness. A
proposed regulation under paragraph (1) classifying such a device
in a class other than class III shall be accompanied by a full
statement of the reasons of the Secretary (and supporting
documentation and data) for not classifying such device in such
class and an identification of the risks to health (if any)
presented by such device.
(3) In the case of devices classified in class II and devices
classified under this subsection in class III and described in
section 360e(b)(1) of this title the Secretary may establish
priorities which, in his discretion, shall be used in applying
sections 360d and 360e of this title, as appropriate, to such
devices.
(e) Classification changes
(1) Based on new information respecting a device, the Secretary
may, upon his own initiative or upon petition of an interested
person, by regulation (A) change such device's classification, and
(B) revoke, because of the change in classification, any regulation
or requirement in effect under section 360d or 360e of this title
with respect to such device. In the promulgation of such a
regulation respecting a device's classification, the Secretary may
secure from the panel to which the device was last referred
pursuant to subsection (c) of this section a recommendation
respecting the proposed change in the device's classification and
shall publish in the Federal Register any recommendation submitted
to the Secretary by the panel respecting such change. A regulation
under this subsection changing the classification of a device from
class III to class II may provide that such classification shall
not take effect until the effective date of a performance standard
established under section 360d of this title for such device.
(2) By regulation promulgated under paragraph (1), the Secretary
may change the classification of a device from class III -
(A) to class II if the Secretary determines that special
controls would provide reasonable assurance of the safety and
effectiveness of the device and that general controls would not
provide reasonable assurance of the safety and effectiveness of
the device, or
(B) to class I if the Secretary determines that general
controls would provide reasonable assurance of the safety and
effectiveness of the device.
(f) Initial classification and reclassification of certain devices
(1) Any device intended for human use which was not introduced or
delivered for introduction into interstate commerce for commercial
distribution before May 28, 1976, is classified in class III unless
-
(A) the device -
(i) is within a type of device (I) which was introduced or
delivered for introduction into interstate commerce for
commercial distribution before such date and which is to be
classified pursuant to subsection (b) of this section, or (II)
which was not so introduced or delivered before such date and
has been classified in class I or II, and
(ii) is substantially equivalent to another device within
such type, or
(B) the Secretary in response to a petition submitted under
paragraph (3) has classified such device in class I or II.
A device classified in class III under this paragraph shall be
classified in that class until the effective date of an order of
the Secretary under paragraph (2) or (3) classifying the device in
class I or II.
(2)(A) Any person who submits a report under section 360(k) of
this title for a type of device that has not been previously
classified under this chapter, and that is classified into class
III under paragraph (1), may request, within 30 days after
receiving written notice of such a classification, the Secretary to
classify the device under the criteria set forth in subparagraphs
(A) through (C) of subsection (a)(1) of this section. The person
may, in the request, recommend to the Secretary a classification
for the device. Any such request shall describe the device and
provide detailed information and reasons for the recommended
classification.
(B)(i) Not later than 60 days after the date of the submission of
the request under subparagraph (A), the Secretary shall by written
order classify the device involved. Such classification shall be
the initial classification of the device for purposes of paragraph
(1) and any device classified under this paragraph shall be a
predicate device for determining substantial equivalence under
paragraph (1).
(ii) A device that remains in class III under this subparagraph
shall be deemed to be adulterated within the meaning of section
351(f)(1)(B) of this title until approved under section 360e of
this title or exempted from such approval under section 360j(g) of
this title.
(C) Within 30 days after the issuance of an order classifying a
device under this paragraph, the Secretary shall publish a notice
in the Federal Register announcing such classification.
(3)(A) The Secretary may initiate the reclassification of a
device classified into class III under paragraph (1) of this
subsection or the manufacturer or importer of a device classified
under paragraph (1) may petition the Secretary (in such form and
manner as he shall prescribe) for the issuance of an order
classifying the device in class I or class II. Within thirty days
of the filing of such a petition, the Secretary shall notify the
petitioner of any deficiencies in the petition which prevent the
Secretary from making a decision on the petition.
(B)(i) Upon determining that a petition does not contain any
deficiency which prevents the Secretary from making a decision on
the petition, the Secretary may for good cause shown refer the
petition to an appropriate panel established or authorized to be
used under subsection (b) of this section. A panel to which such a
petition has been referred shall not later than ninety days after
the referral of the petition make a recommendation to the Secretary
respecting approval or denial of the petition. Any such
recommendation shall contain (I) a summary of the reasons for the
recommendation, (II) a summary of the data upon which the
recommendation is based, and (III) an identification of the risks
to health (if any) presented by the device with respect to which
the petition was filed. In the case of a petition for a device
which is intended to be implanted in the human body or which is
purported or represented to be for a use in supporting or
sustaining human life, the panel shall recommend that the petition
be denied unless the panel determines that the classification in
class III of the device is not necessary to provide reasonable
assurance of its safety and effectiveness. If the panel recommends
that such petition be approved, it shall in its recommendation to
the Secretary set forth its reasons for such recommendation.
(ii) The requirements of paragraphs (1) and (2) of subsection (c)
of this section (relating to opportunities for submission of data
and views and recommendations respecting priorities and exemptions
from sections 360, 360i, and 360j(f) of this title) shall apply
with respect to consideration by panels of petitions submitted
under subparagraph (A).
(C)(i) Within ninety days from the date the Secretary receives
the recommendation of a panel respecting a petition (but not later
than 210 days after the filing of such petition) the Secretary
shall by order deny or approve the petition. If the Secretary
approves the petition, the Secretary shall order the classification
of the device into class I or class II in accordance with the
criteria prescribed by subsection (a)(1)(A) or (a)(1)(B) of this
section. In the case of a petition for a device which is intended
to be implanted in the human body or which is purported or
represented to be for a use in supporting or sustaining human life,
the Secretary shall deny the petition unless the Secretary
determines that the classification in class III of the device is
not necessary to provide reasonable assurance of its safety and
effectiveness. An order approving such petition shall be
accompanied by a full statement of the reasons of the Secretary
(and supporting documentation and data) for approving the petition
and an identification of the risks to health (if any) presented by
the device to which such order applies.
(ii) The requirements of paragraphs (1) and (2)(A) of subsection
(d) of this section (relating to publication of recommendations,
opportunity for submission of comments, and exemption from sections
360, 360i, and 360j(f) of this title) shall apply with respect to
action by the Secretary on petitions submitted under subparagraph
(A).
(4) If a manufacturer reports to the Secretary under section
360(k) of this title that a device is substantially equivalent to
another device -
(A) which the Secretary has classified as a class III device
under subsection (b) of this section,
(B) which was introduced or delivered for introduction into
interstate commerce for commercial distribution before December
1, 1990, and
(C) for which no final regulation requiring premarket approval
has been promulgated under section 360e(b) of this title,
the manufacturer shall certify to the Secretary that the
manufacturer has conducted a reasonable search of all information
known or otherwise available to the manufacturer respecting such
other device and has included in the report under section 360(k) of
this title a summary of and a citation to all adverse safety and
effectiveness data respecting such other device and respecting the
device for which the section 360(k) report is being made and which
has not been submitted to the Secretary under section 360i of this
title. The Secretary may require the manufacturer to submit the
adverse safety and effectiveness data described in the report.
(5) The Secretary may not withhold a determination of the initial
classification of a device under paragraph (1) because of a failure
to comply with any provision of this chapter unrelated to a
substantial equivalence decision, including a finding that the
facility in which the device is manufactured is not in compliance
with good manufacturing requirements as set forth in regulations of
the Secretary under section 360j(f) of this title (other than a
finding that there is a substantial likelihood that the failure to
comply with such regulations will potentially present a serious
risk to human health).
(g) Information
Within sixty days of the receipt of a written request of any
person for information respecting the class in which a device has
been classified or the requirements applicable to a device under
this chapter, the Secretary shall provide such person a written
statement of the classification (if any) of such device and the
requirements of this chapter applicable to the device.
(h) Definitions
For purposes of this section and sections 351, 360, 360d, 360e,
360f, 360i, and 360j of this title
(1) a reference to "general controls" is a reference to the
controls authorized by or under sections 351, 352, 360, 360f,
360h, 360i, and 360j of this title,
(2) a reference to "class I", "class II", or "class III" is a
reference to a class of medical devices described in subparagraph
(A), (B), or (C) of subsection (a)(1) of this section, and
(3) a reference to a "panel under section 360c of this title"
is a reference to a panel established or authorized to be used
under this section.
(i) Substantial equivalence
(1)(A) For purposes of determinations of substantial equivalence
under subsection (f) of this section and section 360j(l) of this
title, the term "substantially equivalent" or "substantial
equivalence" means, with respect to a device being compared to a
predicate device, that the device has the same intended use as the
predicate device and that the Secretary by order has found that the
device -
(i) has the same technological characteristics as the predicate
device, or
(ii)(I) has different technological characteristics and the
information submitted that the device is substantially equivalent
to the predicate device contains information, including
appropriate clinical or scientific data if deemed necessary by
the Secretary or a person accredited under section 360m of this
title, that demonstrates that the device is as safe and effective
as a legally marketed device, and (II) does not raise different
questions of safety and effectiveness than the predicate device.
(B) For purposes of subparagraph (A), the term "different
technological characteristics" means, with respect to a device
being compared to a predicate device, that there is a significant
change in the materials, design, energy source, or other features
of the device from those of the predicate device.
(C) To facilitate reviews of reports submitted to the Secretary
under section 360(k) of this title, the Secretary shall consider
the extent to which reliance on postmarket controls may expedite
the classification of devices under subsection (f)(1) of this
section.
(D) Whenever the Secretary requests information to demonstrate
that devices with differing technological characteristics are
substantially equivalent, the Secretary shall only request
information that is necessary to making substantial equivalence
determinations. In making such request, the Secretary shall
consider the least burdensome means of demonstrating substantial
equivalence and request information accordingly.
(E)(i) Any determination by the Secretary of the intended use of
a device shall be based upon the proposed labeling submitted in a
report for the device under section 360(k) of this title. However,
when determining that a device can be found substantially
equivalent to a legally marketed device, the director of the
organizational unit responsible for regulating devices (in this
subparagraph referred to as the "Director") may require a statement
in labeling that provides appropriate information regarding a use
of the device not identified in the proposed labeling if, after
providing an opportunity for consultation with the person who
submitted such report, the Director determines and states in
writing -
(I) that there is a reasonable likelihood that the device will
be used for an intended use not identified in the proposed
labeling for the device; and
(II) that such use could cause harm.
(ii) Such determination shall -
(I) be provided to the person who submitted the report within
10 days from the date of the notification of the Director's
concerns regarding the proposed labeling;
(II) specify the limitations on the use of the device not
included in the proposed labeling; and
(III) find the device substantially equivalent if the
requirements of subparagraph (A) are met and if the labeling for
such device conforms to the limitations specified in subclause
(II).
(iii) The responsibilities of the Director under this
subparagraph may not be delegated.
(F) Not later than 270 days after November 21, 1997, the
Secretary shall issue guidance specifying the general principles
that the Secretary will consider in determining when a specific
intended use of a device is not reasonably included within a
general use of such device for purposes of a determination of
substantial equivalence under subsection (f) of this section or
section 360j(l) of this title.
(2) A device may not be found to be substantially equivalent to a
predicate device that has been removed from the market at the
initiative of the Secretary or that has been determined to be
misbranded or adulterated by a judicial order.
(3)(A) As part of a submission under section 360(k) of this title
respecting a device, the person required to file a premarket
notification under such section shall provide an adequate summary
of any information respecting safety and effectiveness or state
that such information will be made available upon request by any
person.
(B) Any summary under subparagraph (A) respecting a device shall
contain detailed information regarding data concerning adverse
health effects and shall be made available to the public by the
Secretary within 30 days of the issuance of a determination that
such device is substantially equivalent to another device.