21 U.S.C. § 360j : US Code - Section 360J: General provisions respecting control of devices intended for human use

Search 21 U.S.C. § 360j : US Code - Section 360J: General provisions respecting control of devices intended for human use

(a) General rule
Any requirement authorized by or under section 351, 352, 360, or
360i of this title applicable to a device intended for human use
shall apply to such device until the applicability of the
requirement to the device has been changed by action taken under
section 360c, 360d, or 360e of this title or under subsection (g)
of this section, and any requirement established by or under
section 351, 352, 360, or 360i of this title which is inconsistent
with a requirement imposed on such device under section 360d or
360e of this title or under subsection (g) of this section shall
not apply to such device.
(b) Custom devices
Sections 360d and 360e of this title do not apply to any device
which, in order to comply with the order of an individual physician
or dentist (or any other specially qualified person designated
under regulations promulgated by the Secretary after an opportunity
for an oral hearing) necessarily deviates from an otherwise
applicable performance standard or requirement prescribed by or
under section 360e of this title if (1) the device is not generally
available in finished form for purchase or for dispensing upon
prescription and is not offered through labeling or advertising by
the manufacturer, importer, or distributor thereof for commercial
distribution, and (2) such device -
(A)(i) is intended for use by an individual patient named in
such order of such physician or dentist (or other specially
qualified person so designated) and is to be made in a specific
form for such patient, or
(ii) is intended to meet the special needs of such physician or
dentist (or other specially qualified person so designated) in
the course of the professional practice of such physician or
dentist (or other specially qualified person so designated), and
(B) is not generally available to or generally used by other
physicians or dentists (or other specially qualified persons so
designated).
(c) Trade secrets
Any information reported to or otherwise obtained by the
Secretary or his representative under section 360c, 360d, 360e,
360f, 360h, 360i, or 374 of this title or under subsection (f) or
(g) of this section which is exempt from disclosure pursuant to
subsection (a) of section 552 of title 5 by reason of subsection
(b)(4) of such section shall be considered confidential and shall
not be disclosed and may not be used by the Secretary as the basis
for the reclassification of a device from class III to class II or
class I or as the basis for the establishment or amendment of a
performance standard under section 360d of this title for a device
reclassified from class III to class II, except (1) in accordance
with subsection (h) of this section, and (2) that such information
may be disclosed to other officers or employees concerned with
carrying out this chapter or when relevant in any proceeding under
this chapter (other than section 360c or 360d of this title).
(d) Notices and findings
Each notice of proposed rulemaking under section 360c, 360d,
360e, 360f, 360h, or 360i of this title, or under this section, any
other notice which is published in the Federal Register with
respect to any other action taken under any such section and which
states the reasons for such action, and each publication of
findings required to be made in connection with rulemaking under
any such section shall set forth -
(1) the manner in which interested persons may examine data and
other information on which the notice or findings is based, and
(2) the period within which interested persons may present
their comments on the notice or findings (including the need
therefor) orally or in writing, which period shall be at least
sixty days but may not exceed ninety days unless the time is
extended by the Secretary by a notice published in the Federal
Register stating good cause therefor.
(e) Restricted devices
(1) The Secretary may by regulation require that a device be
restricted to sale, distribution, or use -
(A) only upon the written or oral authorization of a
practitioner licensed by law to administer or use such device, or
(B) upon such other conditions as the Secretary may prescribe
in such regulation,
if, because of its potentiality for harmful effect or the
collateral measures necessary to its use, the Secretary determines
that there cannot otherwise be reasonable assurance of its safety
and effectiveness. No condition prescribed under subparagraph (B)
may restrict the use of a device to persons with specific training
or experience in its use or to persons for use in certain
facilities unless the Secretary determines that such a restriction
is required for the safe and effective use of the device. No such
condition may exclude a person from using a device solely because
the person does not have the training or experience to make him
eligible for certification by a certifying board recognized by the
American Board of Medical Specialties or has not been certified by
such a Board. A device subject to a regulation under this
subsection is a restricted device.
(2) The label of a restricted device shall bear such appropriate
statements of the restrictions required by a regulation under
paragraph (1) as the Secretary may in such regulation prescribe.
(f) Good manufacturing practice requirements
(1)(A) The Secretary may, in accordance with subparagraph (B),
prescribe regulations requiring that the methods used in, and the
facilities and controls used for, the manufacture, pre-production
design validation (including a process to assess the performance of
a device but not including an evaluation of the safety or
effectiveness of a device), packing, storage, and installation of a
device conform to current good manufacturing practice, as
prescribed in such regulations, to assure that the device will be
safe and effective and otherwise in compliance with this chapter.
(B) Before the Secretary may promulgate any regulation under
subparagraph (A) he shall -
(i) afford the advisory committee established under paragraph
(3) an opportunity to submit recommendations to him with respect
to the regulation proposed to be promulgated;
(ii) afford opportunity for an oral hearing; and
(iii) ensure that such regulation conforms, to the extent
practicable, with internationally recognized standards defining
quality systems, or parts of the standards, for medical devices.
The Secretary shall provide the advisory committee a reasonable
time to make its recommendation with respect to proposed
regulations under subparagraph (A).
(2)(A) Any person subject to any requirement prescribed by
regulations under paragraph (1) may petition the Secretary for an
exemption or variance from such requirement. Such a petition shall
be submitted to the Secretary in such form and manner as he shall
prescribe and shall -
(i) in the case of a petition for an exemption from a
requirement, set forth the basis for the petitioner's
determination that compliance with the requirement is not
required to assure that the device will be safe and effective and
otherwise in compliance with this chapter,
(ii) in the case of a petition for a variance from a
requirement, set forth the methods proposed to be used in, and
the facilities and controls proposed to be used for, the
manufacture, packing, storage, and installation of the device in
lieu of the methods, facilities, and controls prescribed by the
requirement, and
(iii) contain such other information as the Secretary shall
prescribe.
(B) The Secretary may refer to the advisory committee established
under paragraph (3) any petition submitted under subparagraph (A).
The advisory committee shall report its recommendations to the
Secretary with respect to a petition referred to it within sixty
days of the date of the petition's referral. Within sixty days
after -
(i) the date the petition was submitted to the Secretary under
subparagraph (A), or
(ii) if the petition was referred to an advisory committee, the
expiration of the sixty-day period beginning on the date the
petition was referred to the advisory committee,
whichever occurs later, the Secretary shall by order either deny
the petition or approve it.
(C) The Secretary may approve -
(i) a petition for an exemption for a device from a requirement
if he determines that compliance with such requirement is not
required to assure that the device will be safe and effective and
otherwise in compliance with this chapter, and
(ii) a petition for a variance for a device from a requirement
if he determines that the methods to be used in, and the
facilities and controls to be used for, the manufacture, packing,
storage, and installation of the device in lieu of the methods,
controls, and facilities prescribed by the requirement are
sufficient to assure that the device will be safe and effective
and otherwise in compliance with this chapter.
An order of the Secretary approving a petition for a variance shall
prescribe such conditions respecting the methods used in, and the
facilities and controls used for, the manufacture, packing,
storage, and installation of the device to be granted the variance
under the petition as may be necessary to assure that the device
will be safe and effective and otherwise in compliance with this
chapter.
(D) After the issuance of an order under subparagraph (B)
respecting a petition, the petitioner shall have an opportunity for
an informal hearing on such order.
(3) The Secretary shall establish an advisory committee for the
purpose of advising and making recommendations to him with respect
to regulations proposed to be promulgated under paragraph (1)(A)
and the approval or disapproval of petitions submitted under
paragraph (2). The advisory committee shall be composed of nine
members as follows:
(A) Three of the members shall be appointed from persons who
are officers or employees of any State or local government or of
the Federal Government.
(B) Two of the members shall be appointed from persons who are
representative of interests of the device manufacturing industry;
two of the members shall be appointed from persons who are
representative of the interests of physicians and other health
professionals; and two of the members shall be representative of
the interests of the general public.
Members of the advisory committee who are not officers or employees
of the United States, while attending conferences or meetings of
the committee or otherwise engaged in its business, shall be
entitled to receive compensation at rates to be fixed by the
Secretary, which rates may not exceed the daily equivalent of the
rate in effect for grade GS-18 of the General Schedule, for each
day (including traveltime) they are so engaged; 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. The
Secretary shall designate one of the members of the advisory
committee to serve as its chairman. The Secretary shall furnish the
advisory committee with clerical and other assistance. Section 14
of the Federal Advisory Committee Act shall not apply with respect
to the duration of the advisory committee established under this
paragraph.
(g) Exemption for devices for investigational use
(1) It is the purpose of this subsection to encourage, to the
extent consistent with the protection of the public health and
safety and with ethical standards, the discovery and development of
useful devices intended for human use and to that end to maintain
optimum freedom for scientific investigators in their pursuit of
that purpose.
(2)(A) The Secretary shall, within the one hundred and twenty-day
period beginning on May 28, 1976, by regulation prescribe
procedures and conditions under which devices intended for human
use may upon application be granted an exemption from the
requirements of section 352, 360, 360d, 360e, 360f, 360i, or 379e
of this title or subsection (e) or (f) of this section or from any
combination of such requirements to permit the investigational use
of such devices by experts qualified by scientific training and
experience to investigate the safety and effectiveness of such
devices.
(B) The conditions prescribed pursuant to subparagraph (A) shall
include the following:
(i) A requirement that an application be submitted to the
Secretary before an exemption may be granted and that the
application be submitted in such form and manner as the Secretary
shall specify.
(ii) A requirement that the person applying for an exemption
for a device assure the establishment and maintenance of such
records, and the making of such reports to the Secretary of data
obtained as a result of the investigational use of the device
during the exemption, as the Secretary determines will enable him
to assure compliance with such conditions, review the progress of
the investigation, and evaluate the safety and effectiveness of
the device.
(iii) Such other requirements as the Secretary may determine to
be necessary for the protection of the public health and safety.
(C) Procedures and conditions prescribed pursuant to subparagraph
(A) for an exemption may appropriately vary depending on (i) the
scope and duration of clinical testing to be conducted under such
exemption, (ii) the number of human subjects that are to be
involved in such testing, (iii) the need to permit changes to be
made in the device subject to the exemption during testing
conducted in accordance with a clinical testing plan required under
paragraph (3)(A), and (iv) whether the clinical testing of such
device is for the purpose of developing data to obtain approval for
the commercial distribution of such device.
(3) Procedures and conditions prescribed pursuant to paragraph
(2)(A) shall require, as a condition to the exemption of any device
to be the subject of testing involving human subjects, that the
person applying for the exemption -
(A) submit a plan for any proposed clinical testing of the
device and a report of prior investigations of the device
(including, where appropriate, tests on animals) adequate to
justify the proposed clinical testing -
(i) to the local institutional review committee which has
been established in accordance with regulations of the
Secretary to supervise clinical testing of devices in the
facilities where the proposed clinical testing is to be
conducted, or
(ii) to the Secretary, if -
(I) no such committee exists, or
(II) the Secretary finds that the process of review by such
committee is inadequate (whether or not the plan for such
testing has been approved by such committee),
for review for adequacy to justify the commencement of such
testing; and, unless the plan and report are submitted to the
Secretary, submit to the Secretary a summary of the plan and a
report of prior investigations of the device (including, where
appropriate, tests on animals);
(B) promptly notify the Secretary (under such circumstances and
in such manner as the Secretary prescribes) of approval by a
local institutional review committee of any clinical testing plan
submitted to it in accordance with subparagraph (A);
(C) in the case of a device to be distributed to investigators
for testing, obtain signed agreements from each of such
investigators that any testing of the device involving human
subjects will be under such investigator's supervision and in
accordance with subparagraph (D) and submit such agreements to
the Secretary; and
(D) assure that informed consent will be obtained from each
human subject (or his representative) of proposed clinical
testing involving such device, except where subject to such
conditions as the Secretary may prescribe, the investigator
conducting or supervising the proposed clinical testing of the
device determines in writing that there exists a life threatening
situation involving the human subject of such testing which
necessitates the use of such device and it is not feasible to
obtain informed consent from the subject and there is not
sufficient time to obtain such consent from his representative.
The determination required by subparagraph (D) shall be concurred
in by a licensed physician who is not involved in the testing of
the human subject with respect to which such determination is made
unless immediate use of the device is required to save the life of
the human subject of such testing and there is not sufficient time
to obtain such concurrence.
(4)(A) An application, submitted in accordance with the
procedures prescribed by regulations under paragraph (2), for an
exemption for a device (other than an exemption from section 360f
of this title) shall be deemed approved on the thirtieth day after
the submission of the application to the Secretary unless on or
before such day the Secretary by order disapproves the application
and notifies the applicant of the disapproval of the application.
(B) The Secretary may disapprove an application only if he finds
that the investigation with respect to which the application is
submitted does not conform to procedures and conditions prescribed
under regulations under paragraph (2). Such a notification shall
contain the order of disapproval and a complete statement of the
reasons for the Secretary's disapproval of the application and
afford the applicant opportunity for an informal hearing on the
disapproval order.
(5) The Secretary may by order withdraw an exemption granted
under this subsection for a device if the Secretary determines that
the conditions applicable to the device under this subsection for
such exemption are not met. Such an order may be issued only after
opportunity for an informal hearing, except that such an order may
be issued before the provision of an opportunity for an informal
hearing if the Secretary determines that the continuation of
testing under the exemption with respect to which the order is to
be issued will result in an unreasonable risk to the public health.
(6)(A) Not later than 1 year after November 21, 1997, the
Secretary shall by regulation establish, with respect to a device
for which an exemption under this subsection is in effect,
procedures and conditions that, without requiring an additional
approval of an application for an exemption or the approval of a
supplement to such an application, permit -
(i) developmental changes in the device (including
manufacturing changes) that do not constitute a significant
change in design or in basic principles of operation and that are
made in response to information gathered during the course of an
investigation; and
(ii) changes or modifications to clinical protocols that do not
affect -
(I) the validity of data or information resulting from the
completion of an approved protocol, or the relationship of
likely patient risk to benefit relied upon to approve a
protocol;
(II) the scientific soundness of an investigational plan
submitted under paragraph (3)(A); or
(III) the rights, safety, or welfare of the human subjects
involved in the investigation.
(B) Regulations under subparagraph (A) shall provide that a
change or modification described in such subparagraph may be made
if -
(i) the sponsor of the investigation determines, on the basis
of credible information (as defined by the Secretary) that the
applicable conditions under subparagraph (A) are met; and
(ii) the sponsor submits to the Secretary, not later than 5
days after making the change or modification, a notice of the
change or modification.
(7)(A) In the case of a person intending to investigate the
safety or effectiveness of a class III device or any implantable
device, the Secretary shall ensure that the person has an
opportunity, prior to submitting an application to the Secretary or
to an institutional review committee, to submit to the Secretary,
for review, an investigational plan (including a clinical
protocol). If the applicant submits a written request for a meeting
with the Secretary regarding such review, the Secretary shall, not
later than 30 days after receiving the request, meet with the
applicant for the purpose of reaching agreement regarding the
investigational plan (including a clinical protocol). 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 (including a clinical protocol) for
determining whether there is a reasonable assurance of
effectiveness, and, if available, information regarding the
expected performance from the device.
(B) Any agreement regarding the parameters of an investigational
plan (including a clinical protocol) that is reached between the
Secretary and a sponsor or applicant shall be reduced to writing
and made part of the administrative record by the Secretary. Any
such agreement shall not be changed, except -
(i) with the written agreement of the sponsor or applicant; or
(ii) pursuant to a decision, made in accordance with
subparagraph (C) by the director of the office in which the
device involved is reviewed, that a substantial scientific issue
essential to determining the safety or effectiveness of the
device involved has been identified.
(C) A decision under subparagraph (B)(ii) by the director shall
be in writing, and may be made only after the Secretary has
provided to the sponsor or applicant an opportunity for a meeting
at which the director and the sponsor or applicant are present and
at which the director documents the scientific issue involved.
(h) Release of information respecting safety and effectiveness
(1) The Secretary shall promulgate regulations under which a
detailed summary of information respecting the safety and
effectiveness of a device which information was submitted to the
Secretary and which was the basis for -
(A) an order under section 360e(d)(1)(A) of this title
approving an application for premarket approval for the device or
denying approval of such an application or an order under section
360e(e) of this title withdrawing approval of such an application
for the device,
(B) an order under section 360e(f)(6)(A) of this title revoking
an approved protocol for the device, an order under section
360e(f)(6)(B) of this title declaring a protocol for the device
completed or not completed, or an order under section 360e(f)(7)
of this title revoking the approval of the device, or
(C) an order approving an application under subsection (g) of
this section for an exemption for the device from section 360f of
this title or an order disapproving, or withdrawing approval of,
an application for an exemption under such subsection for the
device,
shall be made available to the public upon issuance of the order.
Summaries of information made available pursuant to this paragraph
respecting a device shall include information respecting any
adverse effects on health of the device.
(2) The Secretary shall promulgate regulations under which each
advisory committee established under section 360e(g)(2)(B) of this
title shall make available to the public a detailed summary of
information respecting the safety and effectiveness of a device
which information was submitted to the advisory committee and which
was the basis for its recommendation to the Secretary made pursuant
to section 360e(g)(2)(A) of this title. A summary of information
upon which such a recommendation is based shall be made available
pursuant to this paragraph only after the issuance of the order
with respect to which the recommendation was made and each summary
shall include information respecting any adverse effect on health
of the device subject to such order.
(3) Except as provided in paragraph (4), any information
respecting a device which is made available pursuant to paragraph
(1) or (2) of this subsection (A) may not be used to establish the
safety or effectiveness of another device for purposes of this
chapter by any person other than the person who submitted the
information so made available, and (B) shall be made available
subject to subsection (c) of this section.
(4)(A) Any information contained in an application for premarket
approval filed with the Secretary pursuant to section 360e(c) of
this title (including information from clinical and preclinical
tests or studies that demonstrate the safety and effectiveness of a
device, but excluding descriptions of methods of manufacture and
product composition and other trade secrets) shall be available, 6
years after the application has been approved by the Secretary, for
use by the Secretary in -
(i) approving another device;
(ii) determining whether a product development protocol has
been completed, under section 360e of this title for another
device;
(iii) establishing a performance standard or special control
under this chapter; or
(iv) classifying or reclassifying another device under section
360c of this title and subsection (l)(2) of this section.
(B) The publicly available detailed summaries of information
respecting the safety and effectiveness of devices required by
paragraph (1)(A) shall be available for use by the Secretary as the
evidentiary basis for the agency actions described in subparagraph
(A).
(i) Proceedings of advisory panels and committees
Each panel under section 360c of this title and each advisory
committee established under section 360d(b)(5)(B) or 360e(g) of
this title or under subsection (f) of this section shall make and
maintain a transcript of any proceeding of the panel or committee.
Each such panel and committee shall delete from any transcript made
pursuant to this subsection information which under subsection (c)
of this section is to be considered confidential.
(j) Traceability
Except as provided in section 360i(e) of this title, no
regulation under this chapter may impose on a type or class of
device requirements for the traceability of such type or class of
device unless such requirements are necessary to assure the
protection of the public health.
(k) Research and development
The Secretary may enter into contracts for research, testing, and
demonstrations respecting devices and may obtain devices for
research, testing, and demonstration purposes without regard to
section 3324(a) and (b) of title 31 and section 5 of title 41.
(l) Transitional provisions for devices considered as new drugs
(1) Any device intended for human use -
(A) for which on May 28, 1976 (hereinafter in this subsection
referred to as the "enactment date") an approval of an
application submitted under section 355(b) of this title was in
effect;
(B) for which such an application was filed on or before the
enactment date and with respect to which application no order of
approval or refusing to approve had been issued on such date
under subsection (c) or (d) of such section;
(C) for which on the enactment date an exemption under
subsection (i) of such section was in effect;
(D) which is within a type of device described in subparagraph
(A), (B), or (C) and is substantially equivalent to another
device within that type;
(E) which the Secretary in a notice published in the Federal
Register before the enactment date has declared to be a new drug
subject to section 355 of this title; or
(F) with respect to which on the enactment date an action is
pending in a United States court under section 332, 333, or 334
of this title for an alleged violation of a provision of section
331 of this title which enforces a requirement of section 355 of
this title or for an alleged violation of section 355(a) of this
title,
is classified in class III unless the Secretary in response to a
petition submitted under paragraph (2) has classified such device
in class I or II.
(2) 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. Except as provided in paragraph
(3)(D)(ii), within one hundred and eighty days after the filing of
a petition under this paragraph, the Secretary shall, after
consultation with the appropriate panel under section 360c of this
title, by order either deny the petition or order the
classification, in accordance with the criteria prescribed by
section 360c(a)(1)(A) of this title or 360c(a)(1)(B) of this title,
of the device in class I or class II.
(3)(A) In the case of a device which is described in paragraph
(1)(A) and which is in class III -
(i) such device shall on the enactment date be considered a
device with an approved application under section 360e of this
title, and
(ii) the requirements applicable to such device before the
enactment date under section 355 of this title shall continue to
apply to such device until changed by the Secretary as authorized
by this chapter.
(B) In the case of a device which is described in paragraph
(1)(B) and which is in class III, an application for such device
shall be considered as having been filed under section 360e of this
title on the enactment date. The period in which the Secretary
shall act on such application in accordance with section 360e(d)(1)
of this title shall be one hundred and eighty days from the
enactment date (or such greater period as the Secretary and the
applicant may agree upon after the Secretary has made the finding
required by section 360e(d)(1)(B)(i) of this title) less the number
of days in the period beginning on the date an application for such
device was filed under section 355 of this title and ending on the
enactment date. After the expiration of such period such device is
required, unless exempt under subsection (g) of this section, to
have in effect an approved application under section 360e of this
title.
(C) A device which is described in paragraph (1)(C) and which is
in class III shall be considered a new drug until the expiration of
the ninety-day period beginning on the date of the promulgation of
regulations under subsection (g) of this section. After the
expiration of such period such device is required, unless exempt
under subsection (g) of this section, to have in effect an approved
application under section 360e of this title.
(D)(i) Except as provided in clauses (ii) and (iii), a device
which is described in subparagraph (D), (E), or (F) of paragraph
(1) and which is in class III is required, unless exempt under
subsection (g) of this section, to have on and after sixty days
after the enactment date in effect an approved application under
section 360e of this title.
(ii) If -
(I) a petition is filed under paragraph (2) for a device
described in subparagraph (D), (E), or (F) of paragraph (1), or
(II) an application for premarket approval is filed under
section 360e of this title for such a device,
within the sixty-day period beginning on the enactment date (or
within such greater period as the Secretary, after making the
finding required under section 360e(d)(1)(B) of this title, and the
petitioner or applicant may agree upon), the Secretary shall act on
such petition or application in accordance with paragraph (2) or
section 360e of this title except that the period within which the
Secretary must act on the petition or application shall be within
the one hundred and twenty-day period beginning on the date the
petition or application is filed. If such a petition or application
is filed within such sixty-day (or greater) period, clause (i) of
this subparagraph shall not apply to such device before the
expiration of such one hundred and twenty-day period, or if such
petition is denied or such application is denied approval, before
the date of such denial, whichever occurs first.
(iii) In the case of a device which is described in subparagraph
(E) of paragraph (1), which the Secretary in a notice published in
the Federal Register after March 31, 1976, declared to be a new
drug subject to section 355 of this title, and which is in class
III -
(I) the device shall, after eighteen months after the enactment
date, have in effect an approved application under section 360e
of this title unless exempt under subsection (g) of this section,
and
(II) the Secretary may, during the period beginning one hundred
and eighty days after the enactment date and ending eighteen
months after such date, restrict the use of the device to
investigational use by experts qualified by scientific training
and experience to investigate the safety and effectiveness of
such device, and to investigational use in accordance with the
requirements applicable under regulations under subsection (g) of
this section to investigational use of devices granted an
exemption under such subsection.
If the requirements under subsection (g) of this section are made
applicable to the investigational use of such a device, they shall
be made applicable in such a manner that the device shall be made
reasonably available to physicians meeting appropriate
qualifications prescribed by the Secretary.
(4) Repealed. Pub. L. 105-115, title I, Sec. 125(b)(2)(E), Nov.
21, 1997, 111 Stat. 2325.
(5)(A) Before December 1, 1991, the Secretary shall by order
require manufacturers of devices described in paragraph (1), which
are subject to revision of classification under subparagraph (B),
to submit to the Secretary a summary of and citation to any
information known or otherwise available to the manufacturers
respecting the devices, including adverse safety or effectiveness
information which has not been submitted under section 360i of this
title. The Secretary may require a manufacturer to submit the
adverse safety or effectiveness data for which a summary and
citation were submitted, if such data are available to the
manufacturer.
(B) Except as provided in subparagraph (C), after the issuance of
an order under subparagraph (A) but before December 1, 1992, the
Secretary shall publish a regulation in the Federal Register for
each device which is classified in class III under paragraph (1)
revising the classification of the device so that the device is
classified into class I or class II, unless the regulation requires
the device to remain in class III. In determining whether to revise
the classification of a device or to require a device to remain in
class III, the Secretary shall apply the criteria set forth in
section 360c(a) of this title. Before the publication of a
regulation requiring a device to remain in class III or revising
its classification, the Secretary shall publish a proposed
regulation respecting the classification of a device under this
subparagraph and provide an opportunity for the submission of
comments on any such regulation. No regulation under this
subparagraph requiring a device to remain in class III or revising
its classification may take effect before the expiration of 90 days
from the date of the publication in the Federal Register of the
proposed regulation.
(C) The Secretary may by notice published in the Federal Register
extend the period prescribed by subparagraph (B) for a device for
an additional period not to exceed 1 year.
(m) Humanitarian device exemption
(1) To the extent consistent with the protection of the public
health and safety and with ethical standards, it is the purpose of
this subsection to encourage the discovery and use of devices
intended to benefit patients in the treatment and diagnosis of
diseases or conditions that affect fewer than 4,000 individuals in
the United States.
(2) The Secretary may grant a request for an exemption from the
effectiveness requirements of sections 360d and 360e of this title
for a device for which the Secretary finds that -
(A) the device is designed to treat or diagnose a disease or
condition that affects fewer than 4,000 individuals in the United
States,
(B) the device would not be available to a person with a
disease or condition referred to in subparagraph (A) unless the
Secretary grants such an exemption and there is no comparable
device, other than under this exemption, available to treat or
diagnose such disease or condition, and
(C) the device will not expose patients to an unreasonable or
significant risk of illness or injury and the probable benefit to
health from the use of the device outweighs the risk of injury or
illness from its use, taking into account the probable risks and
benefits of currently available devices or alternative forms of
treatment.
The request shall be in the form of an application submitted to the
Secretary. Not later than 75 days after the date of the receipt of
the application, the Secretary shall issue an order approving or
denying the application.
(3) No person granted an exemption under paragraph (2) with
respect to a device may sell the device for an amount that exceeds
the costs of research and development, fabrication, and
distribution of the device.
(4) Devices granted an exemption under paragraph (2) may only be
used -
(A) in facilities that have established, in accordance with
regulations of the Secretary, a local institutional review
committee to supervise clinical testing of devices in the
facilities, and
(B) if, before the use of a device, an institutional review
committee approves the use in the treatment or diagnosis of a
disease or condition referred to in paragraph (2)(A), unless a
physician determines in an emergency situation that approval from
a local institutional review committee can not be obtained in
time to prevent serious harm or death to a patient.
In a case described in subparagraph (B) in which a physician uses a
device without an approval from an institutional review committee,
the physician shall, after the use of the device, notify the
chairperson of the local institutional review committee of such
use. Such notification shall include the identification of the
patient involved, the date on which the device was used, and the
reason for the use.
(5) The Secretary may require a person granted an exemption under
paragraph (2) to demonstrate continued compliance with the
requirements of this subsection if the Secretary believes such
demonstration to be necessary to protect the public health or if
the Secretary has reason to believe that the criteria for the
exemption are no longer met.
(6) The Secretary may suspend or withdraw an exemption from the
effectiveness requirements of sections 360d and 360e of this title
for a humanitarian device only after providing notice and an
opportunity for an informal hearing.
(n) Regulation of contact lenses as devices
(1) All contact lenses shall be deemed to be devices under
section 321(h) of this title.
(2) Paragraph (1) shall not be construed as bearing on or being
relevant to the question of whether any product other than a
contact lens is a device as defined by section 321(h) of this title
or a drug as defined by section 321(g) of this title.