H. R. 5651—30
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. 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 deter-
mine 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 equiva-
lent to a predicate device, or if such submission is withdrawn,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 (l) 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 termi-
nated 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 para-
graph (1)(A).
H. R. 5651—31
‘‘(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 Sec-
retary determines by order that the device is substantially
equivalent to a predicate device; or (iii) the Secretary deter-
mines 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 exemp-
tion under subsection (l) or (m) for a critical or semicritical
reprocessed single-use device does not terminate the exemption
under subsection (l) 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 para-
graph (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 para-
graph:
‘‘(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 propri-
etary 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.
H. R. 5651—32
‘‘(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, con-
cerning 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 Regula-
tions.
‘‘(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 applica-
tion 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 applica-
tion 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 proce-
dure.
H. R. 5651—33
‘‘(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.’’.
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 appro-
priate relating to reprocessed single-use devices, including the name
of the reprocessor and whether the device has been reused.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.