21 U.S.C. § 360i : US Code - Section 360I: Records and reports on devices

Search 21 U.S.C. § 360i : US Code - Section 360I: Records and reports on devices

(a) General rule
Every person who is a manufacturer or importer of a device
intended for human use shall establish and maintain such records,
make such reports, and provide such information, as the Secretary
may by regulation reasonably require to assure that such device is
not adulterated or misbranded and to otherwise assure its safety
and effectiveness. Regulations prescribed under the preceding
sentence -
(1) shall require a device manufacturer or importer to report
to the Secretary whenever the manufacturer or importer receives
or otherwise becomes aware of information that reasonably
suggests that one of its marketed devices -
(A) may have caused or contributed to a death or serious
injury, or
(B) has malfunctioned and that such device or a similar
device marketed by the manufacturer or importer would be likely
to cause or contribute to a death or serious injury if the
malfunction were to recur;
(2) shall define the term "serious injury" to mean an injury
that -
(A) is life threatening,
(B) results in permanent impairment of a body function or
permanent damage to a body structure, or
(C) necessitates medical or surgical intervention to preclude
permanent impairment of a body function or permanent damage to
a body structure;
(3) shall require reporting of other significant adverse device
experiences as determined by the Secretary to be necessary to be
reported;
(4) shall not impose requirements unduly burdensome to a device
manufacturer or importer taking into account his cost of
complying with such requirements and the need for the protection
of the public health and the implementation of this chapter;
(5) which prescribe the procedure for making requests for
reports or information shall require that each request made under
such regulations for submission of a report or information to the
Secretary 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 information to the
Secretary shall state the reason or purpose for the submission of
such report or information 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 information required under this
subsection unless required for the medical welfare of an
individual, to determine the safety or effectiveness of a device,
or to verify a record, report, or information submitted under
this chapter; and
(8) may not require a manufacturer or importer of a class I
device to -
(A) maintain for such a device records respecting 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 manufacturer or importer,
or
(ii) on a periodic basis,
unless such report or information is necessary to determine if
the device should be reclassified or if the device is
adulterated or misbranded. and (!1)
In prescribing such regulations, the Secretary shall have due
regard for the professional ethics of the medical profession and
the interests of patients. The prohibitions of paragraph (7) of
this subsection continue to apply to records, reports, and
information concerning any individual who has been a patient,
irrespective of whether or when he ceases to be a patient. The
Secretary shall by regulation require distributors to keep records
and make such records available to the Secretary upon request.
Paragraphs (4) and (8) apply to distributors to the same extent and
in the same manner as such paragraphs apply to manufacturers and
importers.
(b) User reports
(1)(A) Whenever a device user facility receives or otherwise
becomes aware of information that reasonably suggests that a device
has or may have caused or contributed to the death of a patient of
the facility, the facility shall, as soon as practicable but not
later than 10 working days after becoming aware of the information,
report the information to the Secretary and, if the identity of the
manufacturer is known, to the manufacturer of the device. In the
case of deaths, the Secretary may by regulation prescribe a shorter
period for the reporting of such information.
(B) Whenever a device user facility receives or otherwise becomes
aware of -
(i) information that reasonably suggests that a device has or
may have caused or contributed to the serious illness of, or
serious injury to, a patient of the facility, or
(ii) other significant adverse device experiences as determined
by the Secretary by regulation to be necessary to be reported,
the facility shall, as soon as practicable but not later than 10
working days after becoming aware of the information, report the
information to the manufacturer of the device or to the Secretary
if the identity of the manufacturer is not known.
(C) Each device user facility shall submit to the Secretary on an
annual basis a summary of the reports made under subparagraphs (A)
and (B). Such summary shall be submitted on January 1 of each year.
The summary shall be in such form and contain such information from
such reports as the Secretary may require and shall include -
(i) sufficient information to identify the facility which made
the reports for which the summary is submitted,
(ii) in the case of any product which was the subject of a
report, the product name, serial number, and model number,
(iii) the name and the address of the manufacturer of such
device, and
(iv) a brief description of the event reported to the
manufacturer.
(D) For purposes of subparagraphs (A), (B), and (C), a device
user facility shall be treated as having received or otherwise
become aware of information with respect to a device of that
facility when medical personnel who are employed by or otherwise
formally affiliated with the facility receive or otherwise become
aware of information with respect to that device in the course of
their duties.
(2) The Secretary may not disclose the identity of a device user
facility which makes a report under paragraph (1) except in
connection with -
(A) an action brought to enforce section 331(q) of this title,
or
(B) a communication to a manufacturer of a device which is the
subject of a report under paragraph (1).
This paragraph does not prohibit the Secretary from disclosing the
identity of a device user facility making a report under paragraph
(1) or any information in such a report to employees of the
Department of Health and Human Services, to the Department of
Justice, or to the duly authorized committees and subcommittees of
the Congress.
(3) No report made under paragraph (1) by -
(A) a device user facility,
(B) an individual who is employed by or otherwise formally
affiliated with such a facility, or
(C) a physician who is not required to make such a report,
shall be admissible into evidence or otherwise used in any civil
action involving private parties unless the facility, individual,
or physician who made the report had knowledge of the falsity of
the information contained in the report.
(4) A report made under paragraph (1) does not affect any
obligation of a manufacturer who receives the report to file a
report as required under subsection (a) of this section.
(5) With respect to device user facilities:
(A) The Secretary shall by regulation plan and implement a
program under which the Secretary limits user reporting under
paragraphs (1) through (4) to a subset of user facilities that
constitutes a representative profile of user reports for device
deaths and serious illnesses or serious injuries.
(B) During the period of planning the program under
subparagraph (A), paragraphs (1) through (4) continue to apply.
(C) During the period in which the Secretary is providing for a
transition to the full implementation of the program, paragraphs
(1) through (4) apply except to the extent that the Secretary
determines otherwise.
(D) On and after the date on which the program is fully
implemented, paragraphs (1) through (4) do not apply to a user
facility unless the facility is included in the subset referred
to in subparagraph (A).
(E) Not later than 2 years after November 21, 1997, the
Secretary shall submit to the Committee on Commerce of the House
of Representatives, and to the Committee on Labor and Human
Resources of the Senate, a report describing the plan developed
by the Secretary under subparagraph (A) and the progress that has
been made toward the implementation of the plan.
(6) For purposes of this subsection:
(A) The term "device user facility" means a hospital,
ambulatory surgical facility, nursing home, or outpatient
treatment facility which is not a physician's office. The
Secretary may by regulation include an outpatient diagnostic
facility which is not a physician's office in such term.
(B) The terms "serious illness" and "serious injury" mean
illness or injury, respectively, that -
(i) is life threatening,
(ii) results in permanent impairment of a body function or
permanent damage to a body structure, or
(iii) necessitates medical or surgical intervention to
preclude permanent impairment of a body function or permanent
damage to a body structure.
(c) Persons exempt
Subsection (a) of this section 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 practice;
(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 360j(g) of this title);
and
(3) any other class of persons as the Secretary may by
regulation exempt from subsection (a) of this section upon a
finding that compliance with the requirements of such subsection
by such class with respect to a device is not necessary to (A)
assure that a device is not adulterated or misbranded or (B)
otherwise to assure its safety and effectiveness.
(d) Repealed. Pub. L. 105-115, title II, Sec. 213(a)(2), Nov. 21,
1997, 111 Stat. 2347
(e) Device tracking
(1) The Secretary may by order require a manufacturer to adopt a
method of tracking a class II or class III device -
(A) the failure of which would be reasonably likely to have
serious adverse health consequences; or
(B) which is -
(i) intended to be implanted in the human body for more than
one year, or
(ii) a life sustaining or life supporting device used outside
a device user facility.
(2) Any patient receiving a device subject to tracking under
paragraph (1) may refuse to release, or refuse permission to
release, the patient's name, address, social security number, or
other identifying information for the purpose of tracking.
(f) Reports of removals and corrections
(1) Except as provided in paragraph (2), the Secretary shall by
regulation require a manufacturer or importer of a device to report
promptly to the Secretary any correction or removal of a device
undertaken by such manufacturer or importer if the removal or
correction was undertaken -
(A) to reduce a risk to health posed by the device, or
(B) to remedy a violation of this chapter caused by the device
which may present a risk to health.
A manufacturer or importer of a device who undertakes a correction
or removal of a device which is not required to be reported under
this paragraph shall keep a record of such correction or removal.
(2) No report of the corrective action or removal of a device may
be required under paragraph (1) if a report of the corrective
action or removal is required and has been submitted under
subsection (a) of this section.
(3) For purposes of paragraphs (1) and (2), the terms
"correction" and "removal" do not include routine servicing.