
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC360g]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
                        Part A--Drugs and Devices
 
Sec. 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.

(June 25, 1938, ch. 675, Sec. 517, as added Pub. L. 94-295, Sec. 2, May 
28, 1976, 90 Stat. 560; amended Pub. L. 101-629, Sec. 13, Nov. 28, 1990, 
104 Stat. 4524; Pub. L. 102-300, Sec. 6(f), June 16, 1992, 106 Stat. 
240; Pub. L. 105-115, title II, Sec. 216(a)(2), Nov. 21, 1997, 111 Stat. 
2349.)


                               Amendments

    1997--Subsec. (a)(8). Pub. L. 105-115, Sec. 216(a)(2)(A), inserted 
``or'' at end.
    Subsec. (a)(9). Pub. L. 105-115, Sec. 216(a)(2)(B), substituted 
comma for ``, or'' at end.
    Subsec. (a)(10). Pub. L. 105-115, Sec. 216(a)(2)(C), struck out par. 
(10) which read as follows: ``an order under section 360j(h)(4)(B) of 
this title,''.
    1992--Subsec. (a)(10). Pub. L. 102-300 substituted ``360j(h)(4)(B)'' 
for ``360j(c)(4)(B)''.
    1990--Subsec. (a)(8) to (10). Pub. L. 101-629 added pars. (8) to 
(10).


                    Effective Date of 1997 Amendment

    Amendment by Pub. L. 105-115 effective 90 days after Nov. 21, 1997, 
except as otherwise provided, see section 501 of Pub. L. 105-115, set 
out as a note under section 321 of this title.
