SINGLE-USE MEDICAL DEVICES.

SEC. 302. SINGLE-USE MEDICAL DEVICES. (a) Required Statements on Labeling.— (1) In general.—Section 502 of the Federal Food, Drug, and Cosmetic Act, as amended by section 301 of this Act, is amended by adding at the end the following: “(v) If it is a reprocessed single-use device, unless all labeling of the device prominently and conspicuously bears the statement ‘Reprocessed device for single use. Reprocessed by .’ The name of the manufacturer of the reprocessed device shall be placed in the space identifying the person responsible for reprocessing.”. (2) Effective date.—The amendment made by paragraph (1) takes effect 15 months after the date of the enactment of this Act, and only applies to devices introduced or delivered for introduction into interstate commerce after such effective date. (b) Premarket Notification.— Section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) is amended by inserting after subsection (n) the following: “(o)(1) With respect to reprocessed single-use devices for which reports are required under subsection (k): “(A) The Secretary shall identify such devices or types of devices for which reports under such subsection must, in order to ensure that the device is substantially equivalent to a predicate device, include validation data, the types of which shall be specified by the Secretary, regarding cleaning and sterilization, and functional performance demonstrating 116 STAT. 1617that the single-use device will remain substantially equivalent to its predicate device after the maximum number of times the device is reprocessed as intended by the person submitting the premarket notification. Within six months after enactment of this subsection, the Secretary shall publish in the Federal Register a list of the types so identified, and shall revise the list as appropriate. Reports under subsection (k) for devices or types of devices within a type included on the list are, upon publication of the list, required to include such validation data. “(B) In the case of each report under subsection (k) that was submitted to the Secretary before the publication of the initial list under subparagraph (A), or any revision thereof, and was for a device or type of device included on such list, the person who submitted the report under subsection (k) shall submit validation data as described in subparagraph (A) to the Secretary not later than nine months after the publication of the list. During such nine-month period, the Secretary may not take any action under this Act against such device solely on the basis that the validation data for the device have not been submitted to the Secretary. After the submission of the validation data to the Secretary, the Secretary may not determine that the device is misbranded under section 502(o), adulterated under section 501(f)(1)(B), or take action against the device under section 301(p) for failure to provide any information required by subsection (k) until (i) the review is terminated by withdrawal of the submission of the report under subsection (k); (ii) the Secretary finds the data to be acceptable and issues a letter; or (iii) the Secretary determines that the device is not substantially equivalent to a predicate device. Upon a determination that a device is not substantially equivalent to a predicate device, or if such submission is withdrawn, the device can no longer be legally marketed. “(C) In the case of a report under subsection (k) for a device identified under subparagraph (A) that is of a type for which the Secretary has not previously received a report under such subsection, the Secretary may, in advance of revising the list under subparagraph (A) to include such type, require that the report include the validation data specified in subparagraph (A). “(D) Section 502(o) applies with respect to the failure of a report under subsection (k) to include validation data required under subparagraph (A). “(2) With respect to critical or semi-critical reprocessed single use devices that, under subsection (1) or (m), are exempt from the requirement of submitting reports under subsection (k): “(A) The Secretary shall identify such devices or types of devices for which such exemptions should be terminated in order to provide a reasonable assurance of the safety and effectiveness of the devices. The Secretary shall publish in the Federal Register a list of the devices or types of devices so identified, and shall revise the list as appropriate. The exemption for each device or type included on the list is terminated upon the publication of the list. For each report under subsection (k) submitted pursuant to this subparagraph the Secretary shall require the validation data described in paragraph (1)(A). 116 STAT. 1618 “(B) For each device or type of device included on the list under subparagraph (A), a report under subsection (k) shall be submitted to the Secretary not later than 15 months after the publication of the initial list, or a revision of the list, whichever terminates the exemption for the device. During such 15-month period, the Secretary may not take any action under this Act against such device solely on the basis that such report has not been submitted to the Secretary. After the submission of the report to the Secretary the Secretary may not determine that the device is misbranded under section 502(o), adulterated under section 501(f)(1)(B), or take action against the device under section 301(p) for failure to provide any information required by subsection (k) until (i) the review is terminated by withdrawal of the submission; (ii) the Secretary determines by order that the device is substantially equivalent to a predicate device; or (iii) the Secretary determines by order that the device is not substantially equivalent to a predicate device. Upon a determination that a device is not substantially equivalent to a predicate device, the device can no longer be legally marketed. “(C) In the case of semi-critical devices, the initial list under subparagraph (A) shall be published not later than 18 months after the effective date of this subsection. In the case of critical devices, the initial list under such subparagraph shall be published not later than six months after such effective date. “(D) Section 502(o) applies with respect to the failure to submit a report under subsection (k) that is required pursuant to subparagraph (A), including a failure of the report to include validation data required in such subparagraph. “(E) The termination under subparagraph (A) of an exemption under subsection (1) or (m) for a critical or semicritical reprocessed single-use device does not terminate the exemption under subsection (1) or (m) for the original device.”. (c) Premarket Report.—Section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) is amended— (1) in subsection (a), in the matter after and below paragraph (2), by inserting before the period the following: “or, as applicable, an approval under subsection (c)(2) of a report seeking premarket approval”; and (2) in subsection (c)— (A) by redesignating paragraph (2) as paragraph (3); and (B) by inserting after paragraph (1) the following paragraph: “(2)(A) Any person may file with the Secretary a report seeking premarket approval for a class III device referred to in subsection (a) 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 514. 116 STAT. 1619 “(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 510(o)(1)(A) 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) 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 Act to an application under this section, other than such a reference in section 737 or 738, shall be considered to be a reference to a report under subparagraph (A). “(iv) Each reference in other sections of this Act 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 737 or 738, 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.”. (d) Definitions.—Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the following: (ll)(1) The term ‘single-use device’ means a device that is intended for one use, or on a single patient during a single procedure. 116 STAT. 1620 “(2)(A) The term ‘reprocessed’, with respect to a single-use device, means an original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient. The subsequent processing and manufacture of a reprocessed single-use device shall result in a device that is reprocessed within the meaning of this definition. “(B) A single-use device that meets the definition under clause (A) shall be considered a reprocessed device without regard to any description of the device used by the manufacturer of the device or other persons, including a description that uses the term ‘recycled’ rather than the term ‘reprocessed’. “(3) The term ‘original device’ means a new, unused single use device. “(mm)(1) The term ‘critical reprocessed single-use device’ means a reprocessed single-use device that is intended to contact normally sterile tissue or body spaces during use. “(2) The term ‘semi-critical reprocessed single-use device’ means a reprocessed single-use device that is intended to contact intact mucous membranes and not penetrate normally sterile areas of the body.”.