21 U.S.C. § 360e : US Code - Section 360E: Premarket approval

Search 21 U.S.C. § 360e : US Code - Section 360E: Premarket approval

(a) General requirement
A class III device -
(1) which is subject to a regulation promulgated under
subsection (b) of this section; or
(2) which is a class III device because of section 360c(f) of
this title,
is required to have, unless exempt under section 360j(g) of this
title, an approval under this section of an application for
premarket approval or, as applicable, an approval under subsection
(c)(2) of this section of a report seeking premarket approval.
(b) Regulation to require premarket approval
(1) In the case of a class III device which -
(A) was introduced or delivered for introduction into
interstate commerce for commercial distribution before May 28,
1976; or
(B) is (i) of a type so introduced or delivered, and (ii) is
substantially equivalent to another device within that type,
the Secretary shall by regulation, promulgated in accordance with
this subsection, require that such device have an approval under
this section of an application for premarket approval.
(2)(A) A proceeding for the promulgation of a regulation under
paragraph (1) respecting a device shall be initiated by the
publication in the Federal Register of a notice of proposed
rulemaking. Such notice shall contain -
(i) the proposed regulation;
(ii) proposed findings with respect to the degree of risk of
illness or injury designed to be eliminated or reduced by
requiring the device to have an approved application for
premarket approval and the benefit to the public from use of the
device;
(iii) opportunity for the submission of comments on the
proposed regulation and the proposed findings; and
(iv) opportunity to request a change in the classification of
the device based on new information relevant to the
classification of the device.
(B) If, within fifteen days after publication of a notice under
subparagraph (A), the Secretary receives a request for a change in
the classification of a device, he shall, within sixty days of the
publication of such notice and after consultation with the
appropriate panel under section 360c of this title, by order
published in the Federal Register, either deny the request for
change in classification or give notice of his intent to initiate
such a change under section 360c(e) of this title.
(3) After the expiration of the period for comment on a proposed
regulation and proposed findings published under paragraph (2) and
after consideration of comments submitted on such proposed
regulation and findings, the Secretary shall (A) promulgate such
regulation and publish in the Federal Register findings on the
matters referred to in paragraph (2)(A)(ii), or (B) publish a
notice terminating the proceeding for the promulgation of the
regulation together with the reasons for such termination. If a
notice of termination is published, the Secretary shall (unless
such notice is issued because the device is a banned device under
section 360f of this title) initiate a proceeding under section
360c(e) of this title to reclassify the device subject to the
proceeding terminated by such notice.
(4) The Secretary, upon his own initiative or upon petition of an
interested person, may by regulation amend or revoke any regulation
promulgated under this subsection. A regulation to amend or revoke
a regulation under this subsection shall be promulgated in
accordance with the requirements prescribed by this subsection for
the promulgation of the regulation to be amended or revoked.
(c) Application for premarket approval
(1) Any person may file with the Secretary an application for
premarket approval for a class III device. Such an application for
a device shall contain -
(A) full reports of all information, published or known to or
which should reasonably be known to the applicant, concerning
investigations which have been made to show whether or not such
device is safe and effective;
(B) a full statement of the components, ingredients, and
properties and of the principle or principles of operation, of
such device;
(C) a full description of the methods used in, and the
facilities and controls used for, the manufacture, processing,
and, when relevant, packing and installation of, such device;
(D) an identifying reference to any performance standard under
section 360d of this title which would be applicable to any
aspect of such device if it were a class II device, and either
adequate information to show that such aspect of such device
fully meets such performance standard or adequate information to
justify any deviation from such standard;
(E) such samples of such device and of components thereof as
the Secretary may reasonably require, except that where the
submission of such samples is impracticable or unduly burdensome,
the requirement of this subparagraph may be met by the submission
of complete information concerning the location of one or more
such devices readily available for examination and testing;
(F) specimens of the labeling proposed to be used for such
device; and
(G) such other information relevant to the subject matter of
the application as the Secretary, with the concurrence of the
appropriate panel under section 360c of this title, may require.
(2)(A) Any person may file with the Secretary a report seeking
premarket approval for a class III device referred to in subsection
(a) of this section that is a reprocessed single-use device. Such a
report shall contain the following:
(i) The device name, including both the trade or proprietary
name and the common or usual name.
(ii) The establishment registration number of the owner or
operator submitting the report.
(iii) Actions taken to comply with performance standards under
section 360d of this title.
(iv) Proposed labels, labeling, and advertising sufficient to
describe the device, its intended use, and directions for use.
(v) Full reports of all information, published or known to or
which should be reasonably known to the applicant, concerning
investigations which have been made to show whether or not the
device is safe or effective.
(vi) A description of the device's components, ingredients, and
properties.
(vii) A full description of the methods used in, and the
facilities and controls used for, the reprocessing and packing of
the device.
(viii) Such samples of the device that the Secretary may
reasonably require.
(ix) A financial certification or disclosure statement or both,
as required by part 54 of title 21, Code of Federal Regulations.
(x) A statement that the applicant believes to the best of the
applicant's knowledge that all data and information submitted to
the Secretary are truthful and accurate and that no material fact
has been omitted in the report.
(xi) Any additional data and information, including information
of the type required in paragraph (1) for an application under
such paragraph, that the Secretary determines is necessary to
determine whether there is reasonable assurance of safety and
effectiveness for the reprocessed device.
(xii) Validation data described in section 360(o)(1)(A) of this
title that demonstrates that the reasonable assurance of the
safety or effectiveness of the device will remain after the
maximum number of times the device is reprocessed as intended by
the person submitting such report.
(B) In the case of a class III device referred to in subsection
(a) of this section that is a reprocessed single-use device:
(i) Subparagraph (A) of this paragraph applies in lieu of
paragraph (1).
(ii) Subject to clause (i), the provisions of this section
apply to a report under subparagraph (A) to the same extent and
in the same manner as such provisions apply to an application
under paragraph (1).
(iii) Each reference in other sections of this chapter to an
application under this section, other than such a reference in
section 379i or 379j of this title, shall be considered to be a
reference to a report under subparagraph (A).
(iv) Each reference in other sections of this chapter to a
device for which an application under this section has been
approved, or has been denied, suspended, or withdrawn, other than
such a reference in section 379i or 379j of this title, shall be
considered to be a reference to a device for which a report under
subparagraph (A) has been approved, or has been denied,
suspended, or withdrawn, respectively.
(3) Upon receipt of an application meeting the requirements set
forth in paragraph (1), the Secretary -
(A) may on the Secretary's own initiative, or
(B) shall, upon the request of an applicant unless the
Secretary finds that the information in the application which
would be reviewed by a panel substantially duplicates information
which has previously been reviewed by a panel appointed under
section 360c of this title,
refer such application to the appropriate panel under section 360c
of this title for study and for submission (within such period as
he may establish) of a report and recommendation respecting
approval of the application, together with all underlying data and
the reasons or basis for the recommendation. Where appropriate, the
Secretary shall ensure that such panel includes, or consults with,
one or more pediatric experts.
(4)(A) Prior to the submission of an application under this
subsection, the Secretary shall accept and review any portion of
the application that the applicant and the Secretary agree is
complete, ready, and appropriate for review, except that such
requirement does not apply, and the Secretary has discretion
whether to accept and review such portion, during any period in
which, under section 379j(g) of this title, the Secretary does not
have the authority to collect fees under section 379j(a) of this
title.
(B) Each portion of a submission reviewed under subparagraph (A)
and found acceptable by the Secretary shall not be further reviewed
after receipt of an application that satisfies the requirements of
paragraph (1), unless a significant issue of safety or
effectiveness provides the Secretary reason to review such accepted
portion.
(C) Whenever the Secretary determines that a portion of a
submission under subparagraph (A) is unacceptable, the Secretary
shall, in writing, provide to the applicant a description of any
deficiencies in such portion and identify the information that is
required to correct these deficiencies, unless the applicant is no
longer pursuing the application.
(d) Action on application for premarket approval
(1)(A) As promptly as possible, but in no event later than one
hundred and eighty days after the receipt of an application under
subsection (c) of this section (except as provided in section
360j(l)(3)(D)(ii) of this title or unless, in accordance with
subparagraph (B)(i), an additional period as agreed upon by the
Secretary and the applicant), the Secretary, after considering the
report and recommendation submitted under paragraph (2) of such
subsection, shall -
(i) issue an order approving the application if he finds that
none of the grounds for denying approval specified in paragraph
(2) of this subsection applies; or
(ii) deny approval of the application if he finds (and sets
forth the basis for such finding as part of or accompanying such
denial) that one or more grounds for denial specified in
paragraph (2) of this subsection apply.
In making the determination whether to approve or deny the
application, the Secretary shall rely on the conditions of use
included in the proposed labeling as the basis for determining
whether or not there is a reasonable assurance of safety and
effectiveness, if the proposed labeling is neither false nor
misleading. In determining whether or not such labeling is false or
misleading, the Secretary shall fairly evaluate all material facts
pertinent to the proposed labeling.
(B)(i) The Secretary may not enter into an agreement to extend
the period in which to take action with respect to an application
submitted for a device subject to a regulation promulgated under
subsection (b) of this section unless he finds that the continued
availability of the device is necessary for the public health.
(ii) An order approving an application for a device may require
as a condition to such approval that the sale and distribution of
the device be restricted but only to the extent that the sale and
distribution of a device may be restricted under a regulation under
section 360j(e) of this title.
(iii) The Secretary shall accept and review statistically valid
and reliable data and any other information from investigations
conducted under the authority of regulations required by section
360j(g) of this title to make a determination of whether there is a
reasonable assurance of safety and effectiveness of a device
subject to a pending application under this section if -
(I) the data or information is derived from investigations of
an earlier version of the device, the device has been modified
during or after the investigations (but prior to submission of an
application under subsection (c) of this section) and such a
modification of the device does not constitute a significant
change in the design or in the basic principles of operation of
the device that would invalidate the data or information; or
(II) the data or information relates to a device approved under
this section, is available for use under this chapter, and is
relevant to the design and intended use of the device for which
the application is pending.
(2) The Secretary shall deny approval of an application for a
device if, upon the basis of the information submitted to the
Secretary as part of the application and any other information
before him with respect to such device, the Secretary finds that -
(A) there is a lack of a showing of reasonable assurance that
such device is safe under the conditions of use prescribed,
recommended, or suggested in the proposed labeling thereof;
(B) there is a lack of a showing of reasonable assurance that
the device is effective under the conditions of use prescribed,
recommended, or suggested in the proposed labeling thereof;
(C) the methods used in, or the facilities or controls used
for, the manufacture, processing, packing, or installation of
such device do not conform to the requirements of section 360j(f)
of this title;
(D) based on a fair evaluation of all material facts, the
proposed labeling is false or misleading in any particular; or
(E) such device is not shown to conform in all respects to a
performance standard in effect under section 360d of this title
compliance with which is a condition to approval of the
application and there is a lack of adequate information to
justify the deviation from such standard.
Any denial of an application shall, insofar as the Secretary
determines to be practicable, be accompanied by a statement
informing the applicant of the measures required to place such
application in approvable form (which measures may include further
research by the applicant in accordance with one or more protocols
prescribed by the Secretary).
(3)(A)(i) The Secretary shall, upon the written request of an
applicant, meet with the applicant, not later than 100 days after
the receipt of an application that has been filed as complete under
subsection (c) of this section, to discuss the review status of the
application.
(ii) The Secretary shall, in writing and prior to the meeting,
provide to the applicant a description of any deficiencies in the
application that, at that point, have been identified by the
Secretary based on an interim review of the entire application and
identify the information that is required to correct those
deficiencies.
(iii) The Secretary shall notify the applicant promptly of -
(I) any additional deficiency identified in the application, or
(II) any additional information required to achieve completion
of the review and final action on the application,
that was not described as a deficiency in the written description
provided by the Secretary under clause (ii).
(B) The Secretary and the applicant may, by mutual consent,
establish a different schedule for a meeting required under this
paragraph.
(4) An applicant whose application has been denied approval may,
by petition filed on or before the thirtieth day after the date
upon which he receives notice of such denial, obtain review thereof
in accordance with either paragraph (1) or (2) of subsection (g) of
this section, and any interested person may obtain review, in
accordance with paragraph (1) or (2) of subsection (g) of this
section, of an order of the Secretary approving an application.
(5) In order to provide for more effective treatment or diagnosis
of life-threatening or irreversibly debilitating human diseases or
conditions, the Secretary shall provide review priority for devices
-
(A) representing breakthrough technologies,
(B) for which no approved alternatives exist,
(C) which offer significant advantages over existing approved
alternatives, or
(D) the availability of which is in the best interest of the
patients.
(6)(A)(i) A supplemental application shall be required for any
change to a device subject to an approved application under this
subsection that affects safety or effectiveness, unless such change
is a modification in a manufacturing procedure or method of
manufacturing and the holder of the approved application submits a
written notice to the Secretary that describes in detail the
change, summarizes the data or information supporting the change,
and informs the Secretary that the change has been made under the
requirements of section 360j(f) of this title.
(ii) The holder of an approved application who submits a notice
under clause (i) with respect to a manufacturing change of a device
may distribute the device 30 days after the date on which the
Secretary receives the notice, unless the Secretary within such 30-
day period notifies the holder that the notice is not adequate and
describes such further information or action that is required for
acceptance of such change. If the Secretary notifies the holder
that a supplemental application is required, the Secretary shall
review the supplement within 135 days after the receipt of the
supplement. The time used by the Secretary to review the notice of
the manufacturing change shall be deducted from the 135-day review
period if the notice meets appropriate content requirements for
premarket approval supplements.
(B)(i) Subject to clause (ii), in reviewing a supplement to an
approved application, for an incremental change to the design of a
device that affects safety or effectiveness, the Secretary shall
approve such supplement if -
(I) nonclinical data demonstrate that the design modification
creates the intended additional capacity, function, or
performance of the device; and
(II) clinical data from the approved application and any
supplement to the approved application provide a reasonable
assurance of safety and effectiveness for the changed device.
(ii) The Secretary may require, when necessary, additional
clinical data to evaluate the design modification of the device to
provide a reasonable assurance of safety and effectiveness.
(e) Withdrawal and temporary suspension of approval of application
(1) The Secretary shall, upon obtaining, where appropriate,
advice on scientific matters from a panel or panels under section
360c of this title, and after due notice and opportunity for
informal hearing to the holder of an approved application for a
device, issue an order withdrawing approval of the application if
the Secretary finds -
(A) that such device is unsafe or ineffective under the
conditions of use prescribed, recommended, or suggested in the
labeling thereof;
(B) on the basis of new information before him with respect to
such device, evaluated together with the evidence available to
him when the application was approved, that there is a lack of a
showing of reasonable assurance that the device is safe or
effective under the conditions of use prescribed, recommended, or
suggested in the labeling thereof;
(C) that the application contained or was accompanied by an
untrue statement of a material fact;
(D) that the applicant (i) has failed to establish a system for
maintaining records, or has repeatedly or deliberately failed to
maintain records or to make reports, required by an applicable
regulation under section 360i(a) of this title, (ii) has refused
to permit access to, or copying or verification of, such records
as required by section 374 of this title, or (iii) has not
complied with the requirements of section 360 of this title;
(E) on the basis of new information before him with respect to
such device, evaluated together with the evidence before him when
the application was approved, that the methods used in, or the
facilities and controls used for, the manufacture, processing,
packing, or installation of such device do not conform with the
requirements of section 360j(f) of this title and were not
brought into conformity with such requirements within a
reasonable time after receipt of written notice from the
Secretary of nonconformity;
(F) on the basis of new information before him, evaluated
together with the evidence before him when the application was
approved, that the labeling of such device, based on a fair
evaluation of all material facts, is false or misleading in any
particular and was not corrected within a reasonable time after
receipt of written notice from the Secretary of such fact; or
(G) on the basis of new information before him, evaluated
together with the evidence before him when the application was
approved, that such device is not shown to conform in all
respects to a performance standard which is in effect under
section 360d of this title compliance with which was a condition
to approval of the application and that there is a lack of
adequate information to justify the deviation from such standard.
(2) The holder of an application subject to an order issued under
paragraph (1) withdrawing approval of the application may, by
petition filed on or before the thirtieth day after the date upon
which he receives notice of such withdrawal, obtain review thereof
in accordance with either paragraph (1) or (2) of subsection (g) of
this section.
(3) If, after providing an opportunity for an informal hearing,
the Secretary determines there is reasonable probability that the
continuation of distribution of a device under an approved
application would cause serious, adverse health consequences or
death, the Secretary shall by order temporarily suspend the
approval of the application approved under this section. If the
Secretary issues such an order, the Secretary shall proceed
expeditiously under paragraph (1) to withdraw such application.
(f) Product development protocol
(1) In the case of a class III device which is required to have
an approval of an application submitted under subsection (c) of
this section, such device shall be considered as having such an
approval if a notice of completion of testing conducted in
accordance with a product development protocol approved under
paragraph (4) has been declared completed under paragraph (6).
(2) Any person may submit to the Secretary a proposed product
development protocol with respect to a device. Such a protocol
shall be accompanied by data supporting it. If, within thirty days
of the receipt of such a protocol, the Secretary determines that it
appears to be appropriate to apply the requirements of this
subsection to the device with respect to which the protocol is
submitted, the Secretary -
(A) may, at the initiative of the Secretary, refer the proposed
protocol to the appropriate panel under section 360c of this
title for its recommendation respecting approval of the protocol;
or
(B) shall so refer such protocol upon the request of the
submitter, unless the Secretary finds that the proposed protocol
and accompanying data which would be reviewed by such panel
substantially duplicate a product development protocol and
accompanying data which have previously been reviewed by such a
panel.
(3) A proposed product development protocol for a device may be
approved only if -
(A) the Secretary determines that it is appropriate to apply
the requirements of this subsection to the device in lieu of the
requirement of approval of an application submitted under
subsection (c) of this section; and
(B) the Secretary determines that the proposed protocol
provides -
(i) a description of the device and the changes which may be
made in the device,
(ii) a description of the preclinical trials (if any) of the
device and a specification of (I) the results from such trials
to be required before the commencement of clinical trials of
the device, and (II) any permissible variations in preclinical
trials and the results therefrom,
(iii) a description of the clinical trials (if any) of the
device and a specification of (I) the results from such trials
to be required before the filing of a notice of completion of
the requirements of the protocol, and (II) any permissible
variations in such trials and the results therefrom,
(iv) a description of the methods to be used in, and the
facilities and controls to be used for, the manufacture,
processing, and, when relevant, packing and installation of the
device,
(v) an identifying reference to any performance standard
under section 360d of this title to be applicable to any aspect
of such device,
(vi) if appropriate, specimens of the labeling proposed to be
used for such device,
(vii) such other information relevant to the subject matter
of the protocol as the Secretary, with the concurrence of the
appropriate panel or panels under section 360c of this title,
may require, and
(viii) a requirement for submission of progress reports and,
when completed, records of the trials conducted under the
protocol which records are adequate to show compliance with the
protocol.
(4) The Secretary shall approve or disapprove a proposed product
development protocol submitted under paragraph (2) within one
hundred and twenty days of its receipt unless an additional period
is agreed upon by the Secretary and the person who submitted the
protocol. Approval of a protocol or denial of approval of a
protocol is final agency action subject to judicial review under
chapter 7 of title 5.
(5) At any time after a product development protocol for a device
has been approved pursuant to paragraph (4), the person for whom
the protocol was approved may submit a notice of completion -
(A) stating (i) his determination that the requirements of the
protocol have been fulfilled and that, to the best of his
knowledge, there is no reason bearing on safety or effectiveness
why the notice of completion should not become effective, and
(ii) the data and other information upon which such determination
was made, and
(B) setting forth the results of the trials required by the
protocol and all the information required by subsection (c)(1) of
this section.
(6)(A) The Secretary may, after providing the person who has an
approved protocol and opportunity for an informal hearing and at
any time prior to receipt of notice of completion of such protocol,
issue a final order to revoke such protocol if he finds that -
(i) such person has failed substantially to comply with the
requirements of the protocol,
(ii) the results of the trials obtained under the protocol
differ so substantially from the results required by the protocol
that further trials cannot be justified, or
(iii) the results of the trials conducted under the protocol or
available new information do not demonstrate that the device
tested under the protocol does not present an unreasonable risk
to health and safety.
(B) After the receipt of a notice of completion of an approved
protocol the Secretary shall, within the ninety-day period
beginning on the date such notice is received, by order either
declare the protocol completed or declare it not completed. An
order declaring a protocol not completed may take effect only after
the Secretary has provided the person who has the protocol
opportunity for an informal hearing on the order. Such an order may
be issued only if the Secretary finds -
(i) such person has failed substantially to comply with the
requirements of the protocol,
(ii) the results of the trials obtained under the protocol
differ substantially from the results required by the protocol,
or
(iii) there is a lack of a showing of reasonable assurance of
the safety and effectiveness of the device under the conditions
of use prescribed, recommended, or suggested in the proposed
labeling thereof.
(C) A final order issued under subparagraph (A) or (B) shall be
in writing and shall contain the reasons to support the conclusions
thereof.
(7) At any time after a notice of completion has become
effective, the Secretary may issue an order (after due notice and
opportunity for an informal hearing to the person for whom the
notice is effective) revoking the approval of a device provided by
a notice of completion which has become effective as provided in
subparagraph (B) if he finds that any of the grounds listed in
subparagraphs (A) through (G) of subsection (e)(1) of this section
apply. Each reference in such subparagraphs to an application shall
be considered for purposes of this paragraph as a reference to a
protocol and the notice of completion of such protocol, and each
reference to the time when an application was approved shall be
considered for purposes of this paragraph as a reference to the
time when a notice of completion took effect.
(8) A person who has an approved protocol subject to an order
issued under paragraph (6)(A) revoking such protocol, a person who
has an approved protocol with respect to which an order under
paragraph (6)(B) was issued declaring that the protocol had not
been completed, or a person subject to an order issued under
paragraph (7) revoking the approval of a device may, by petition
filed on or before the thirtieth day after the date upon which he
receives notice of such order, obtain review thereof in accordance
with either paragraph (1) or (2) of subsection (g) of this section.
(g) Review
(1) Upon petition for review of -
(A) an order under subsection (d) of this section approving or
denying approval of an application or an order under subsection
(e) of this section withdrawing approval of an application, or
(B) an order under subsection (f)(6)(A) of this section
revoking an approved protocol, under subsection (f)(6)(B) of this
section declaring that an approved protocol has not been
completed, or under subsection (f)(7) of this section revoking
the approval of a device,
the Secretary shall, unless he finds the petition to be without
good cause or unless a petition for review of such order has been
submitted under paragraph (2), hold a hearing, in accordance with
section 554 of title 5, on the order. The panel or panels which
considered the application, protocol, or device subject to such
order shall designate a member to appear and testify at any such
hearing upon request of the Secretary, the petitioner, or the
officer conducting the hearing, but this requirement does not
preclude any other member of the panel or panels from appearing and
testifying at any such hearing. Upon completion of such hearing and
after considering the record established in such hearing, the
Secretary shall issue an order either affirming the order subject
to the hearing or reversing such order and, as appropriate,
approving or denying approval of the application, reinstating the
application's approval, approving the protocol, or placing in
effect a notice of completion.
(2)(A) Upon petition for review of -
(i) an order under subsection (d) of this section approving or
denying approval of an application or an order under subsection
(e) of this section withdrawing approval of an application, or
(ii) an order under subsection (f)(6)(A) of this section
revoking an approved protocol, under subsection (f)(6)(B) of this
section declaring that an approved protocol has not been
completed, or under subsection (f)(7) of this section revoking
the approval of a device,
the Secretary shall refer the application or protocol subject to
the order and the basis for the order to an advisory committee of
experts established pursuant to subparagraph (B) for a report and
recommendation with respect to the order. The advisory committee
shall, after independent study of the data and information
furnished to it by the Secretary and other data and information
before it, submit to the Secretary a report and recommendation,
together with all underlying data and information and a statement
of the reasons or basis for the recommendation. A copy of such
report shall be promptly supplied by the Secretary to any person
who petitioned for such referral to the advisory committee.
(B) The Secretary shall establish advisory committees (which may
not be panels under section 360c of this title) to receive
referrals under subparagraph (A). The Secretary shall appoint as
members of any such advisory committee persons qualified in the
subject matter to be referred to the committee and of appropriately
diversified professional backgrounds, except that the Secretary may
not appoint to such a committee any individual who is in the
regular full-time employ of the United States and engaged in the
administration of this chapter. Members of an advisory committee
(other than officers or employees of the United States), while
attending conferences or meetings of their committee or otherwise
serving at the request of the Secretary, shall be entitled to
receive compensation at rates to be fixed by the Secretary, which
rates may not exceed the daily equivalent 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 the chairman of an
advisory committee from its members. The Secretary shall furnish
each advisory committee with clerical and other assistance, and
shall by regulation prescribe the procedures to be followed by each
such committee in acting on referrals made under subparagraph (A).
(C) The Secretary shall make public the report and recommendation
made by an advisory committee with respect to an application and
shall by order, stating the reasons therefor, either affirm the
order referred to the advisory committee or reverse such order and,
if appropriate, approve or deny approval of the application,
reinstate the application's approval, approve the protocol, or
place in effect a notice of completion.
(h) Service of orders
Orders of the Secretary under this section shall be served (1) in
person by any officer or employee of the department designated by
the Secretary, or (2) by mailing the order by registered mail or
certified mail addressed to the applicant at his last known address
in the records of the Secretary.
(i) Revision
(1) Before December 1, 1995, the Secretary shall by order require
manufacturers of devices, which were introduced or delivered for
introduction into interstate commerce for commercial distribution
before May 28, 1976, and which are subject to revision of
classification under paragraph (2), to submit to the Secretary a
summary of and citation to any information known or otherwise
available to the manufacturer respecting such devices, including
adverse safety or effectiveness information which has not been
submitted under section 360i of this title. The Secretary may
require the 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.
(2) After the issuance of an order under paragraph (1) but before
December 1, 1995, the Secretary shall publish a regulation in the
Federal Register for each device -
(A) which the Secretary has classified as a class III device,
and
(B) for which no final regulation has been promulgated under
subsection (b) of this section,
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
paragraph and provide reasonable opportunity for the submission of
comments on any such regulation. No regulation 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 its
publication in the Federal Register as a proposed regulation.
(3) The Secretary shall, as promptly as is reasonably achievable,
but not later than 12 months after the effective date of the
regulation requiring a device to remain in class III, establish a
schedule for the promulgation of a subsection (b) of this section
regulation for each device which is subject to the regulation
requiring the device to remain in class III.