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"(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);
(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.
"(iv) Proposed labels, labeling, and advertising sufficient to describe the device, its intended use, and directions for
"(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:
"(11)(1) The term 'single-use device' means a device that is intended for one use, or on a single patient during a single procedure.
"(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 singleuse 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.".
SEC. 303. MEDWATCH.
Not later than 6 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall modify the MedWatch mandatory and voluntary forms to facilitate the reporting of information by user facilities or distributors as appropriate relating to reprocessed single-use devices, including the name of the reprocessor and whether the device has been reused.
Approved October 26, 2002.
LEGISLATIVE HISTORY-H.R. 5651:
Oct. 16, considered and passed House.
Oct. 17, considered and passed Senate.
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 38 (2002):
Oct. 26, 28, Presidential remarks and statement.
NOTE: Part 1 contains pages 1-810; Part 2 contains pages 811-1620; Part 3 contains pages 1621-2456; Part 4 contains
Holocaust Restitution Tax Fairness
Independence Act of 2002............ 1399 Homeland Security Act of 2002......... 2135
Education Sciences Reform Act of
Homeland Security Information
Act of 2002............
Educational Technical Assistance
Enhanced Border Security and
Visa Entry Reform Act of
Enterprise Integration Act of
543 Hydrographic Services
Reauthorization Act of 2002......... 698
Improvement Act Amendments
Improper Payments Information
74 Indian Financing Amendments Act
Investment Act of 2002..................... 134 Inland Flood Forecasting and