Classification of devices intended for human use

There are established the following classes of devices intended for human use: A device for which insufficient information exists to determine that the controls referred to in clause (i) are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but because it— A device which because— For purposes of this section and sections 360d and 360e of this title, the safety and effectiveness of a device are to be determined— If the Secretary determines that there exists valid scientific evidence (other than evidence derived from investigations described in subparagraph (A))— For purposes of— When a device is specifically the subject of review by a classification panel, the Secretary shall— ensure that adequate expertise is represented on the classification panel to assess— For purposes of subparagraph (B)(i), the term “adequate expertise” means that the membership of the classification panel includes— Any person whose device is specifically the subject of review by a classification panel shall have— Any meeting of a classification panel with respect to the review of a device shall— Following the initial presentations described in clause (i), the panel may— In the case of a device which has been referred under paragraph (1) to a panel, and which— Based on new information respecting a device, the Secretary may, upon the initiative of the Secretary or upon petition of an interested person, change the classification of such device, and revoke, on account of the change in classification, any regulation or requirement in effect under section 360d or 360e of this title with respect to such device, by administrative order published in the Federal Register following publication of a proposed reclassification order in the Federal Register, a meeting of a device classification panel described in subsection (b), and consideration of comments to a public docket, notwithstanding subchapter II of chapter 5 of title 5. The proposed reclassification order published in the Federal Register shall set forth the proposed reclassification, and a substantive summary of the valid scientific evidence concerning the proposed reclassification, including— By an order issued under paragraph (1), the Secretary may change the classification of a device from class III— Any device intended for human use which was not introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, is classified in class III unless— the device— If a manufacturer reports to the Secretary under section 360(k) of this title that a device is substantially equivalent to another device— In the case of a device intended to be used with an accessory, where the accessory has been included in an application for premarket approval of such device under section 360e of this title or a report under section 360(k) of this title for clearance of such device and the Secretary has not classified such accessory distinctly from another device in accordance with subparagraph (A), the person filing the application or report (as applicable) at the time such application or report is filed— For accessories that have been granted marketing authorization as part of a submission for another device with which the accessory involved is intended to be used, through an application for such other device under section 360e(c) of this title, a report under section 360(k) of this title, or a request for classification under paragraph (2) of this subsection, the following shall apply: Within sixty days of the receipt of a written request of any person for information respecting the class in which a device has been classified or the requirements applicable to a device under this chapter, the Secretary shall provide such person a written statement of the classification (if any) of such device and the requirements of this chapter applicable to the device. For purposes of this section and sections 351, 360, 360d, 360e, 360f, 360i, and 360j of this title For purposes of determinations of substantial equivalence under subsection (f) and section 360j(l) of this title, the term “substantially equivalent” or “substantial equivalence” means, with respect to a device being compared to a predicate device, that the device has the same intended use as the predicate device and that the Secretary by order has found that the device— Any determination by the Secretary of the intended use of a device shall be based upon the proposed labeling submitted in a report for the device under section 360(k) of this title. However, when determining that a device can be found substantially equivalent to a legally marketed device, the director of the organizational unit responsible for regulating devices (in this subparagraph referred to as the “Director”) may require a statement in labeling that provides appropriate information regarding a use of the device not identified in the proposed labeling if, after providing an opportunity for consultation with the person who submitted such report, the Director determines and states in writing— Such determination shall— The Secretary shall— Not later than 18 months after December 13, 2016, the ombudsman for any organizational unit of the Food and Drug Administration responsible for the premarket review of devices shall— within 30 calendar days of completion of such final audit report, make such final audit report available— For a device authorized for emergency use under section 360bbb–3 of this title for which, in accordance with section 360bbb–3(m) of this title, the Secretary has deemed a laboratory examination or procedure associated with such device to be in the category of examinations and procedures described in section 263a(d)(3) of title 42, the sponsor of such device may, when submitting a request for classification under subsection (f)(2), submit a single submission containing—