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21 U.S. Code § 360e. Premarket approval
(a) General requirementA class III device—
(1)
which is subject to an order issued under subsection (b) (or a regulation promulgated under such subsection prior to July 9, 2012); 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 a report seeking premarket approval.
(b) Order 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 administrative order following publication of a proposed order in the Federal Register, a meeting of a device classification panel described in section 360c(b) of this title, and consideration of comments from all affected stakeholders, including patients, payors, and providers, notwithstanding subchapter II of chapter 5 of title 5, require that such device have an approval under this section of an application for premarket approval. Authority to issue such administrative order shall not be delegated below the Director of the Center for Devices and Radiological Health, acting in consultation with the Commissioner.
(2) A proposed order required under paragraph (1) shall contain—
(A)
the proposed order;
(B)
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;
(C)
opportunity for the submission of comments on the proposed order and the proposed findings; and
(D)
opportunity to request a change in the classification of the device based on new information relevant to the classification of the device.
(3)
After the expiration of the period for comment on a proposed order and proposed findings published under paragraph (2), consideration of comments submitted on such proposed order and findings, and a meeting of a device classification panel described in section 360c(b) of this title, the Secretary shall (A) issue an administrative order under paragraph (1) and publish in the Federal Register findings on the matters referred to in paragraph (2)(B), or (B) publish a notice terminating the proceeding for the issuance of the administrative order 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.
(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;
(G)
the certification required under section 282(j)(5)(B) of title 42 (which shall not be considered an element of such application); and
(H)
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.