[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 3130 Introduced in Senate (IS)]







107th CONGRESS
  2d Session
                                S. 3130

 To amend the Federal Food, Drug, and Cosmetic Act to add requirements 
                regarding device reprocessing and reuse.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            October 17, 2002

Mr. Durbin (for himself and Mr. Gregg) introduced the following bill; 
        which was read twice and referred to the Committee on Health, 
        Education, Labor, and PensionsYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYY

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act to add requirements 
                regarding device reprocessing and reuse.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Safe Reprocessed Medical Devices Act 
of 2002''.

SEC. 2. PURPOSE.

    The purpose of this Act is to--
            (1) increase the safety and medical devices labeled as 
        single-use devices that are reprocessed for additional use;
            (2) provide health professionals with more accurate 
        information on the medical devices that they are using; and
            (3) provide the Food and Drug Administration with more 
        accurate information on adverse events that may be caused by 
        device failure.

SEC. 3. DEVICE REPROCESSING AND REUSE.

    (a) In General.--Section 502 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the 
following:
    ``(u)(1) The reprocessing for reuse of a device (including the 
manufacture or repeated manufacture of a previously used device) that 
is intended for use on a single patient, unless such reprocessed 
device--
            ``(A)(i) is subject to an order under section 515 approving 
        the reprocessed device as safe and effective for the number of 
        intended uses by the reprocessor as set forth in its 
        submission, or
            ``(ii) is subject to an order determining that the 
        reprocessed device is substantially equivalent under 
        subsections (f) and (i) of section 513 to a legally marketed 
        device, specifically taking into account the number of uses 
        specified in the label of the reprocessed device;
            ``(B) is labeled with the number of times the device has 
        been reprocessed;
            ``(C) prominently and conspicuously bears the name of the 
        reprocessor and the original manufacturer of the device, a 
        generally recognized abbreviation of such names, or a unique 
        and generally recognized symbol identifying such manufacturers, 
        except that the Secretary may waive any requirement under this 
        subparagraph with respect to a device if the Secretary 
        determines that compliance with the requirement is not feasible 
        or would compromise the provision of reasonable assurance of 
        the safety or effectiveness of the device; and
            ``(D) prominently and conspicuously bears on its label the 
        following statement: `Reprocessed device for single use 
        reprocessed by ________________' (the name of the reprocessor 
        shall be placed in the blank space to identify the person 
        responsible for reprocessing).
    ``(2)(A) Not later than 60 days after the date of enactment of this 
subsection, the Secretary shall review each reprocessed device that is 
exempt on such date from the requirement to submit a report under 
section 510(k) and shall--
            ``(i) in the case of an exempt class I reprocessed device, 
        determine whether the device is intended for a use which is of 
        substantial importance in preventing impairment of human health 
        or presents a potential unreasonable risk of illness or injury, 
        including a review of the risks presented by reprocessing the 
        device; and
            ``(ii) in the case of an exempt class II reprocessed 
        device, determine whether such a report is necessary to assure 
        the safety and effectiveness of the devices, including a review 
        of the risks presented by reprocessing the device.
The Secretary shall solicit public comment during such 60 day period 
concerning whether each device should remain exempt.
    ``(B) Based on the finding of the review conducted under 
subparagraph (A) the Secretary shall, not later than 120 days after 
such date of enactment, publish in the Federal Register a list of the 
reprocessed devices that are no longer exempt from submission of a 
report under section 510(k). The reprocessor of any such device will be 
required to make a submission under section 510(k) not later than 120 
days after the publication by the Secretary of such list in the Federal 
Register.
    ``(C) During such 120-day period, the Secretary may not determine 
that the device is misbranded under subsection (o) or adulterated under 
section 501(f)(1)(B) 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 subsection (o) or adulterated under section 
501(f)(1)(B) until the Secretary determines the classification of the 
device under section 513 or the Secretary determines that the 
submission was insufficient to make a classification.
    ``(D) Subsection (o) applies with respect to a 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 (l) or (m) for a reprocessed device does not terminate the 
exemption under subsection (l) or (m) for the original device.
    ``(v) The introduction or delivery for introduction into interstate 
commerce of a device which was previously used in a patient and labeled 
in a manner that represents directly or indirectly that the device is 
new or unused.''.
    (b) Exemptions.--Section 510 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360) is amended--
            (1) in subsection (l), by adding at the end the following: 
        ``The Secretary, in determining whether an exemption under this 
        subsection applies, shall consider whether such an exemption 
        would also apply to such a device when reprocessed with 
        consideration given to whether additional risks, if any, from 
        reprocessing should preclude such an exemption.''; and
            (2) in subsection (m), by adding at the end the following:
    ``(3) The Secretary in determining whether an exemption under this 
subsection applies shall consider whether such an exemption would also 
apply to such a device when reprocessed with consideration given to 
whether additional risks, if any, from reprocessing should preclude 
such an exemption.''.
    (c) Premarket Notification.--Section 510 of the Federal Food, Drug 
and Cosmetic Act (21 U.S.C. 360) is amended by adding at the end the 
following:
    ``(o) With respect to reprocessed single-use devices for which 
reports are required under subsection (k):
            ``(1)(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 that 
        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.
            ``(B) Not later than 60 days after the date of enactment of 
        this subsection, the Secretary shall publish in the Federal 
        Register a list of the device types identified under 
        subparagraph (A), and shall revise the list as appropriate.
            ``(C) Reports under subsection (k) for devices or types of 
        devices within a type included on the list under subparagraph 
        (B) are, upon publication of the list, required to include such 
        validation data.
            ``(2)(A) In the case of each report under subsection (k) 
        that was submitted to the Secretary prior to the publication of 
        the initial list under paragraph (1), or any revision thereof, 
        and that 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 paragraph (1) to 
        the Secretary not later than 9 months after the publication of 
        the list under paragraph (1)(B).
            ``(B) During the 9-month period described in subparagraph 
        (A), the Secretary may not take any action under this Act 
        against a device solely on the basis that the validation data 
        for the device has not been submitted to the Secretary.
            ``(C) 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 under clause (iii), the device 
        may no longer be legally marketed.
            ``(3) In the case of a report under subsection (k) for a 
        device identified under paragraph (1) 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 paragraph (1) to include such type, require that the 
        report include the validation data specified in paragraph (1).
            ``(4) Section 502(o) applies with respect to the failure of 
        a report under subsection (k) to include validation data 
        required under paragraph (1).''.
    (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) The term `single-use device' means a disposable device that 
is intended for one use or use on a single patient in a single 
procedure.
    ``(mm)(1) The term `reprocessed', with respect to a single-use 
device, means an original device that was used as intended and then 
subsequently was subject 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.
    ``(2) A single-use device that meets the definition under paragraph 
(1) 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'.
    ``(nn) The term `original device' means a new, unused single use 
device.''.

SEC. 4. MEDWATCH.

    Not later than 6 months after the date of enactment of this Act, 
the Secretary of Health and Human Services shall modify the MEDWATCH 
voluntary and mandatory forms to facilitate the reporting of 
information by user facilities or distributors as appropriate relating 
to reprocessed devices, including the name of the reprocessor and 
whether the device has been reused.
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