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state the reason or purpose for such request and
identify to the fullest extent practicable such report
or information;
‘‘(6) which require submission of a report or in-
formation to the Secretary shall state the reason or
purpose for the submission of such report or infor-
mation and identify to the fullest extent practicable
such report or information;
‘‘(7) may not require that the identity of any
patient be disclosed in records, reports, or informa-
tion required under this subsection unless required
for the medical welfare of an individual, to deter-
mine the safety or effectiveness of a device, or to
verify a record, report, or information submitted
under this Act;
‘‘(8) may not require a manufacturer, importer,
or distributor of a class I device to—
‘‘(A) maintain for such a device records re-
specting information not in the possession of
the manufacturer or importer, or
‘‘(B) to submit for such a device to the
Secretary any report or information—
‘‘(i) not in the possession of the man-
ufacturer or importer, or
‘‘(ii) on a periodic basis,
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unless such report or information is necessary to de-
termine if the device should be reclassified or if the
device is adulterated or misbranded; and
‘‘(b) Subsection (a) shall not apply to—
‘‘(1) any practitioner who is licensed by law to
prescribe or administer devices intended for use in
humans and who manufactures or imports devices
solely for use in the course of his professional prac-
tice;
‘‘(2) any person who manufactures or imports
devices intended for use in humans solely for such
person’s use in research or teaching and not for sale
(including any person who uses a device under an
exemption granted under section 520(g)); and
‘‘(3) any other class of persons as the Secretary
may by regulation exempt from subsection (a) upon
a finding that compliance with the requirements of
such subsection by such class with respect to a de-
vice is not necessary to (A) assure that a device is
not adulterated or misbranded or (B) otherwise to
assure its safety and effectiveness.
‘‘(c) Each manufacturer and importer required to
make reports under subsection (a) shall submit to the Sec-
retary annually a statement certifying that—
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‘‘(1) the manufacturer or importer did file a
certain number of such reports, or
‘‘(2) the manufacturer or importer did not file
any report under subsection (a).
‘‘(d) Every person who registers under section 510
and is engaged in the manufacture of—
‘‘(1) a device the failure of which would be rea-
sonably likely to have serious adverse health con-
sequences 
and 
which 
is 
(A) 
a 
permanently
implantable device, or (B) a life sustaining or life
supporting device used outside a device user facility,
or
‘‘(2) any other device which the Secretary may
designate,
shall adopt a method of device tracking.’’.
(b) Within 120 days after the enactment of this sec-
tion, the Secretary shall delete all regulations in title 21,
part 800 requiring distributors, other than importers, to
make reports of deaths, serious injuries or illness, and
malfunctions related to devices.
(c) Section 303(c) (21 U.S.C. 333) is amended by
striking the period at the end of subsection (c) and insert-
ing ‘‘; or for having violated 301(a), (b), (c), and (k), by
failure to comply with either subsections 502(t)(2) or
501(h), or having violated subsection 301(g)(1)(B) by fail-
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ing to furnish material or information required under sub-
section 519(a) if such person acted in good faith, had no
reason to believe that the person’s acts violated the law,
and had no prior notice from the Secretary that the acts
constituted violations of the Act.’’.
(d) Section 201(h) (21 U.S.C. 321(h)) is amended
by striking paragraph (1), and renumbering paragraphs
(2), and (3) as paragraphs (1) and (2), respectively.
(e) The Secretary of Health and Human Services
within 120 days of the enactment of this section shall re-
vise all regulations appearing in part 800 of title 21 of
the Code of Federal Regulations to delete any requirement
to report device malfunctions.
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