
From the U.S. Code Online via GPO Access
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[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC360i]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
                        Part A--Drugs and Devices
 
Sec. 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\
---------------------------------------------------------------------------
    \1\ So in original. The word ``and'' probably should not appear.

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.

(June 25, 1938, ch. 675, Sec. 519, as added Pub. L. 94-295, Sec. 2, May 
28, 1976, 90 Stat. 564; amended Pub. L. 101-629, Secs. 2(a), 3(a)(1), 
(b)(1), 7, Nov. 28, 1990, 104 Stat. 4511, 4513, 4514, 4520; Pub. L. 102-
300, Sec. 5(a), June 16, 1992, 106 Stat. 239; Pub. L. 103-80, Sec. 3(u), 
Aug. 13, 1993, 107 Stat. 778; Pub. L. 105-115, title II, Secs. 211, 
213(a), (c), Nov. 21, 1997, 111 Stat. 2345-2347.)


                               Amendments

    1997--Subsec. (a). Pub. L. 105-115, Sec. 213(a)(1)(A), (F), in 
introductory provisions, substituted ``manufacturer or importer'' for 
``manufacturer, importer, or distributor'' and, in closing provisions, 
inserted at end ``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.''
    Subsec. (a)(4). Pub. L. 105-115, Sec. 213(a)(1)(B), substituted 
``manufacturer or importer'' for ``manufacturer, importer, or 
distributor''.
    Subsec. (a)(7). Pub. L. 105-115, Sec. 213(a)(1)(C), inserted ``and'' 
after semicolon at end.
    Subsec. (a)(8). Pub. L. 105-115, Sec. 213(a)(1)(D), substituted 
``manufacturer or importer'' for ``manufacturer, importer, or 
distributor'' wherever appearing and substituted period for semicolon 
after ``misbranded''.
    Subsec. (a)(9). Pub. L. 105-115, Sec. 213(a)(1)(E), struck out par. 
(9) which read as follows: ``shall require distributors who submit such 
reports to submit copies of the reports to the manufacturer of the 
device for which the report was made.''
    Subsec. (b)(1)(C). Pub. L. 105-115, Sec. 213(c)(1)(A), in 
introductory provisions, substituted ``on an annual basis'' for ``on a 
semi-annual basis'' and struck out ``and July 1'' after ``January 1'' 
and struck out closing provisions which read as follows: ``The Secretary 
may by regulation alter the frequency and timing of reports required by 
this subparagraph.''
    Subsec. (b)(2)(A). Pub. L. 105-115, Sec. 213(c)(1)(B)(i), inserted 
``or'' after comma at end.
    Subsec. (b)(2)(B). Pub. L. 105-115, Sec. 213(c)(1)(B)(ii), 
substituted period for ``, or'' at end.
    Subsec. (b)(2)(C). Pub. L. 105-115, Sec. 213(c)(1)(B)(iii), struck 
out subpar. (C) which read as follows: ``a disclosure required under 
subsection (a) of this section.''
    Subsec. (b)(5), (6). Pub. L. 105-115, Sec. 213(c)(2), added par. (5) 
and redesignated former par. (5) as (6).
    Subsec. (d). Pub. L. 105-115, Sec. 213(a)(2), struck out heading and 
text of subsec. (d). Text read as follows: ``Each manufacturer, 
importer, and distributor required to make reports under subsection (a) 
of this section shall submit to the Secretary annually a statement 
certifying that--
        ``(1) the manufacturer, importer, or distributor did file a 
    certain number of such reports, or
        ``(2) the manufacturer, importer, or distributor did not file 
    any report under subsection (a) of this section.''
    Subsec. (e). Pub. L. 105-115, Sec. 211, amended heading and text of 
subsec. (e) generally. Prior to amendment, text read as follows: ``Every 
person who registers under section 360 of this title and is engaged in 
the manufacture of--
        ``(1) a device the failure of which would be reasonably likely 
    to have serious adverse health consequences 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.''
    Subsec. (f)(1). Pub. L. 105-115, Sec. 213(a)(3), substituted ``or 
importer'' for ``, importer, or distributor'' wherever appearing.
    1993--Subsec. (a). Pub. L. 103-80 substituted ``paragraph (7)'' for 
``paragraph (4)'' in last sentence.
    1992--Subsec. (a). Pub. L. 102-300, Sec. 5(a)(1), added pars. (1) to 
(3) and redesignated former pars. (1) to (6) as (4) to (9), 
respectively.
    Subsec. (b)(1)(A). Pub. L. 102-300, Sec. 5(a)(2)(A), substituted ``a 
device has or may have'' for ``there is a probability that a device 
has''.
    Subsec. (b)(1)(B). Pub. L. 102-300, Sec. 5(a)(2)(A), (B), 
substituted ``a device has or may have'' for ``there is a probability 
that a device has'', designated existing provisions as cl. (i), and 
added cl. (ii).
    Subsec. (b)(5)(B)(iii). Pub. L. 102-300, Sec. 5(a)(2)(C), struck out 
``immediate'' before ``medical''.
    1990--Subsec. (a)(6). Pub. L. 101-629, Sec. 3(a)(1), added par. (6).
    Subsecs. (b), (c). Pub. L. 101-629, Sec. 2(a), added subsec. (b) and 
redesignated former subsec. (b) as (c).
    Subsecs. (d), (e). Pub. L. 101-629, Sec. 3(b)(1), added subsecs. (d) 
and (e).
    Subsec. (f). Pub. L. 101-629, Sec. 7, added subsec. (f).


                    Effective Date of 1997 Amendment

    Section 211 of Pub. L. 105-115 provided in part that the amendment 
made by that section is effective 90 days after Nov. 21, 1997.
    Amendment by section 213(a), (c) of Pub. L. 105-115 effective 90 
days after Nov. 21, 1997, except as otherwise provided, see section 501 
of Pub. L. 105-115, set out as a note under section 321 of this title.


                    Effective Date of 1992 Amendment

    Section 2(b) of Pub. L. 102-300 provided that: ``The amendments made 
by subsection (a) [amending sections 3(b)(3) and 3(c) of Pub. L. 101-
629, set out as notes below] shall take effect as of May 27, 1992 and 
any rule to implement section 519(e) of the Federal Food, Drug, and 
Cosmetic Act [21 U.S.C. 360i(e)] proposed under section 3(c)(2) of the 
Safe Medical Devices Act of 1990 [Pub. L. 101-629, set out as a note 
below] shall revert to its proposed status as of such date.''
    Section 5(b) of Pub. L. 102-300 provided that: ``The amendments made 
by subsection (a) [amending this section] shall take effect--
        ``(1) 1 year after the date of the enactment of this Act [June 
    16, 1992]; or
        ``(2) on the effective date of regulations of the Secretary to 
    implement such amendments,
whichever occurs first.''


                    Effective Date of 1990 Amendment

    Section 2(c) of Pub. L. 101-629 provided that: ``Section 519(b) of 
the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360i(b)], as added 
by the amendment made by subsection (a), shall take effect--
        ``(1) upon the effective date of regulations promulgated under 
    subsection (b) [set out below], or
        ``(2) upon the expiration of 12 months from the date of the 
    enactment of this Act [Nov. 28, 1990],
whichever occurs first.''
    Section 3(a)(2) of Pub. L. 101-629 provided that: ``Section 
519(a)(6) [21 U.S.C. 360i(a)(6)], as added by the amendment made by 
paragraph (1), shall take effect upon the effective date of final 
regulations under subsection (c) [set out below].''
    Section 3(b)(3) of Pub. L. 101-629, as amended by Pub. L. 102-300, 
Sec. 2(a)(1), June 16, 1992, 106 Stat. 238, provided that: ``Section 
519(e) [21 U.S.C. 360i(e)], as added by the amendment made by paragraph 
(1), shall take effect upon the expiration of 9 months after the 
issuance of final regulations under subsection (c) [set out below].''
    [For effective date of amendment by Pub. L. 102-300, see section 
2(b) of Pub. L. 102-300, set out above as an Effective Date of 1992 
Amendment note.]


                               Regulations

    Section 2(b) of Pub. L. 101-629 provided that: ``The Secretary of 
Health and Human Services shall promulgate regulations to implement 
section 519(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 
360i(b)], as added by the amendment made by subsection (a) (including a 
definition of the summary required by paragraph (1)(C) of such section) 
not later than 12 months after the date of enactment of this Act [Nov. 
28, 1990]. In promulgating the regulations, the Secretary shall minimize 
the administrative burdens on device user facilities consistent with the 
need to assure adequate information.''
    Section 3(c) of Pub. L. 101-629, as amended by Pub. L. 102-300, 
Sec. 2(a)(2), (3), June 16, 1992, 106 Stat. 238, provided that:
    ``(1)(A) Not later than 9 months after the date of the enactment of 
this Act [Nov. 28, 1990], the Secretary of Health and Human Services 
shall issue proposed regulations--
        ``(i) to require distributors of devices to establish and 
    maintain records and to make reports (including reports required by 
    part 803 of title 21 of the Code of Federal Regulations) under 
    section 519(a)(6) of the Federal Food, Drug, and Cosmetic Act [21 
    U.S.C. 360i(a)(6)], and
        ``(ii) to implement section 519(e) of such Act.
The Secretary may exempt from regulations described in clause (i) 
classes of distributors of class I and class II devices from whom 
reports are not necessary for the protection of the public health.
    ``(B) Regulations under subparagraph (A) shall--
        ``(i) require appropriate methods for maintenance of records to 
    ensure that patients who receive devices can be provided the 
    notification required by such Act [this chapter],
        ``(ii) require that manufacturers adopt effective methods of 
    tracking devices,
        ``(iii) take into account the position of distributors in the 
    device distribution process, and
        ``(iv) include such other requirements as the Secretary deems 
    necessary for the adoption of an effective user tracking program 
    under section 519(e) of such Act.
    ``(2) Not later than 18 months after the date of the enactment of 
this Act, the Secretary shall issue final regulations to implement 
sections [sic] 519(a)(6) of the Federal Food, Drug, and Cosmetic Act. If 
the Secretary does not promulgate such final regulations upon the 
expiration of such 18 months, the Congress finds that there is good 
cause for the proposed regulations to be considered as the final 
regulations without response to comment because the implementation of 
sections [sic] 519(a)(6) of such Act is essential to protect the health 
of patients who use such devices. Consequently, in such event, the 
proposed regulations issued under paragraph (1) shall become final 
regulations as of the expiration of such 18 months. There shall be 
promptly published in the Federal Register notice of the new status of 
the proposed regulations.
    ``(3) Not later than November 28, 1992, the Secretary shall issue 
final regulations to implement section 519(e) of the Federal Food, Drug, 
and Cosmetic Act. If the Secretary does not promulgate such final 
regulations by November 28, 1992, the Congress finds that there is good 
cause for the proposed regulations to be considered as the final 
regulations without response to comment because the implementation of 
section 519(e) of such Act is essential to protect the health of 
patients who use devices. In such event, the proposed regulations issued 
under paragraph (1) shall become the issued final regulations on 
November 29, 1992. There shall be promptly published in the Federal 
Register notice of the new status of the proposed regulations.''
    [For effective date of amendment by Pub. L. 102-300, see section 
2(b) of Pub. L. 102-300, set out above as an Effective Date of 1992 
Amendment note.]


Information Concerning Reporting Requirements for Device User Facilities

    Section 2(d) of Pub. L. 101-629 directed Secretary of Health and 
Human Services, during the 18-month period beginning on Nov. 28, 1990, 
to inform device user facilities (as defined in 21 U.S.C. 360i(b)(5)(A)) 
and manufacturers and distributors of devices respecting the 
requirements of 21 U.S.C. 360i(b), and, to the extent practicable, 
provide persons subject to such requirements assistance in the form of 
publications regarding such requirements.


 Study of Reporting Requirements; Compliance by Device User Facilities; 
      Actions by Manufacturers; Cost Effectiveness; Recommendations

    Section 2(e) of Pub. L. 101-629 directed Comptroller General of the 
United States, not more than 36 months after Nov. 28, 1990, to conduct a 
study of compliance by device user facilities with the requirements of 
21 U.S.C. 360i(b), actions taken by manufacturers of devices in response 
to reports made to them, cost effectiveness of such requirements and 
their implementation, and any recommendations for improvements to such 
requirements, with Comptroller General to complete the study and submit 
a report on the study not later than 45 months from Nov. 28, 1990, to 
appropriate committees of Congress.


 Report to Congress on Reporting Requirements for Device User Facilities

    Section 2(f) of Pub. L. 101-629 directed Secretary of Health and 
Human Services, not later than 36 months after Nov. 28, 1990, to prepare 
and submit to appropriate committees of Congress a report containing an 
evaluation of the requirements of 21 U.S.C. 360i(b), consisting of an 
evaluation of the safety benefits of the requirements, the burdens 
placed on the Food and Drug Administration and on device user facilities 
by the requirements, and the cost-effectiveness of the requirements and 
recommendations for legislative reform.

                  Section Referred to in Other Sections

    This section is referred to in sections 331, 333, 352, 360c, 360e, 
360g, 360j, 374 of this title.
