21 U.S.C. § 360g : US Code - Section 360G: Judicial review

Search 21 U.S.C. § 360g : US Code - Section 360G: Judicial review

(a) Petition; record
Not later than thirty days after -
(1) the promulgation of a regulation under section 360c of this
title classifying a device in class I or changing the
classification of a device to class I or an order under
subsection (f)(2) of such section reclassifying a device or
denying a petition for reclassification of a device,
(2) the promulgation of a regulation under section 360d of this
title establishing, amending, or revoking a performance standard
for a device,
(3) the issuance of an order under section 360d(b)(2) or
360e(b)(2)(B) of this title denying a request for
reclassification of a device,
(4) the promulgation of a regulation under paragraph (3) of
section 360e(b) of this title requiring a device to have an
approval of a premarket application, a regulation under paragraph
(4) of that section amending or revoking a regulation under
paragraph (3), or an order pursuant to section 360e(g)(1) or
360e(g)(2)(C) of this title,
(5) the promulgation of a regulation under section 360f of this
title (other than a proposed regulation made effective under
subsection (b) of such section upon the regulation's publication)
making a device a banned device,
(6) the issuance of an order under section 360j(f)(2) of this
title,
(7) an order under section 360j(g)(4) of this title
disapproving an application for an exemption of a device for
investigational use or an order under section 360j(g)(5) of this
title withdrawing such an exemption for a device,
(8) an order pursuant to section 360c(i) of this title, or
(9) a regulation under section 360e(i)(2) or 360j(l)(5)(B) of
this title,
any person adversely affected by such regulation or order may file
a petition with the United States Court of Appeals for the District
of Columbia or for the circuit wherein such person resides or has
his principal place of business for judicial review of such
regulation or order. A copy of the petition shall be transmitted by
the clerk of the court to the Secretary or other officer designated
by him for that purpose. The Secretary shall file in the court the
record of the proceedings on which the Secretary based his
regulation or order as provided in section 2112 of title 28. For
purposes of this section, the term "record" means all notices and
other matter published in the Federal Register with respect to the
regulation or order reviewed, all information submitted to the
Secretary with respect to such regulation or order, proceedings of
any panel or advisory committee with respect to such regulation or
order, any hearing held with respect to such regulation or order,
and any other information identified by the Secretary, in the
administrative proceeding held with respect to such regulation or
order, as being relevant to such regulation or order.
(b) Additional data, views, and arguments
If the petitioner applies to the court for leave to adduce
additional data, views, or arguments respecting the regulation or
order being reviewed and shows to the satisfaction of the court
that such additional data, views, or arguments are material and
that there were reasonable grounds for the petitioner's failure to
adduce such data, views, or arguments in the proceedings before the
Secretary, the court may order the Secretary to provide additional
opportunity for the oral presentation of data, views, or arguments
and for written submissions. The Secretary may modify his findings,
or make new findings by reason of the additional data, views, or
arguments so taken and shall file with the court such modified or
new findings, and his recommendation, if any, for the modification
or setting aside of the regulation or order being reviewed, with
the return of such additional data, views, or arguments.
(c) Standard for review
Upon the filing of the petition under subsection (a) of this
section for judicial review of a regulation or order, the court
shall have jurisdiction to review the regulation or order in
accordance with chapter 7 of title 5 and to grant appropriate
relief, including interim relief, as provided in such chapter. A
regulation described in paragraph (2) or (5) of subsection (a) of
this section and an order issued after the review provided by
section 360e(g) of this title shall not be affirmed if it is found
to be unsupported by substantial evidence on the record taken as a
whole.
(d) Finality of judgments
The judgment of the court affirming or setting aside, in whole or
in part, any regulation or order shall be final, subject to review
by the Supreme Court of the United States upon certiorari or
certification, as provided in section 1254 of title 28.
(e) Remedies
The remedies provided for in this section shall be in addition to
and not in lieu of any other remedies provided by law.
(f) Statement of reasons
To facilitate judicial review under this section or under any
other provision of law of a regulation or order issued under
section 360c, 360d, 360e, 360f, 360h, 360i, 360j, or 360k of this
title each such regulation or order shall contain a statement of
the reasons for its issuance and the basis, in the record of the
proceedings held in connection with its issuance, for its issuance.