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 sub-
mitting 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 ap-
plies 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 con-
sidered to be a reference to a report under subpara-
graph (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, sus-
pended, or withdrawn, other than such a reference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 sub-
paragraph (A) has been approved, or has been de-
nied, suspended, or withdrawn, respectively.’’.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.
‘‘(2)(A) The term ‘reprocessed’, with respect to a sin-
gle-use device, means an original device that has pre-
viously 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 in-
tended 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 in-
tended to contact intact mucous membranes and not pene-
trate normally sterile areas of the body.’’.
SEC. 303. MEDWATCH.
Not later than 6 months after the date of the enact-
ment of this Act, the Secretary of Health and Human
Services shall modify the MedWatch mandatory and vol-
untary forms to facilitate the reporting of information by
user facilities or distributors as appropriate relating to re-
processed single-use devices, including the name of the re-
processor and whether the device has been reused.
Passed the House of Representatives October 16,
2002.
Attest:
Clerk.
107TH CONGRESS
2D SESSION
H. R. 5651
AN ACT
To amend the Federal Food, Drug, and Cosmetic
Act to make improvements in the regulation of
medical devices, and for other purposes.