![]() |
United States Code (Last Updated: May 24, 2014) |
![]() |
Title 21. FOOD AND DRUGS |
![]() |
Chapter 9. FEDERAL FOOD, DRUG, AND COSMETIC ACT |
![]() |
SubChapter V. DRUGS AND DEVICES |
![]() |
Part A. Drugs and Devices |
§ 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, which report under this subparagraph— (i) shall be submitted in accordance with part 803 of title 21, Code of Federal Regulations (or successor regulations), unless the Secretary grants an exemption or variance from, or an alternative to, a requirement under such regulations pursuant to section 803.19 of such part, if the device involved is— (I) a class III device; (II) a class II device that is permanently implantable, is life supporting, or is life sustaining; or (III) a type of device which the Secretary has, by notice published in the Federal Register or letter to the person who is the manufacturer or importer of the device, indicated should be subject to such part 803 in order to protect the public health; (ii) shall, if the device is not subject to clause (i), be submitted in accordance with criteria established by the Secretary for reports made pursuant to this clause, which criteria shall require the reports to be in summary form and made on a quarterly basis; or (iii) shall, if the device is imported into the United States and for which part 803 of title 21, Code of Federal Regulations (or successor regulations) requires an importer to submit a report to the manufacturer, be submitted by the importer to the manufacturer in accordance with part 803 of title 21, Code of Federal Regulations (or successor regulations) 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, § 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) Unique device identification system Not later than
December 31, 2012 , the Secretary shall issue proposed regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device through distribution and use, and may include information on the lot or serial number. The Secretary shall finalize the proposed regulations not later than 6 months after the close of the comment period and shall implement the final regulations with respect to devices that are implantable, life-saving, and life sustaining not later than 2 years after the regulations are finalized, taking into account patient access to medical devices and therapies.(g) 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. (h) Inclusion of devices in the postmarket risk identification and analysis system (1) In general (A) Application to devices The Secretary shall amend the procedures established and maintained under clauses (i), (ii), (iii), and (v) of section 355(k)(3)(C) of this title in order to expand the postmarket risk identification and analysis system established under such section to include and apply to devices.
(B) Exception Subclause (II) of clause (i) of section 355(k)(3)(C) of this title shall not apply to devices.
(C) Clarification With respect to devices, the private sector health-related electronic data provided under section 355(k)(3)(C)(i)(III)(bb) of this title may include medical device utilization data, health insurance claims data, and procedure and device registries.
(2) Data In expanding the system as described in paragraph (1)(A), the Secretary shall use relevant data with respect to devices cleared under section 360(k) of this title or approved under section 360e of this title, including claims data, patient survey data, and any other data deemed appropriate by the Secretary.
(3) Stakeholder input To help ensure effective implementation of the system as described in paragraph (1) with respect to devices, the Secretary shall engage outside stakeholders in development of the system, and gather information from outside stakeholders regarding the content of an effective sentinel program, through a public hearing, advisory committee meeting, maintenance of a public docket, or other similar public measures.
(4) Voluntary surveys Chapter 35 of title 44 shall not apply to the collection of voluntary information from health care providers, such as voluntary surveys or questionnaires, initiated by the Secretary for purposes of postmarket risk identification, mitigation, and analysis for devices.
Amendments
2012—Subsec. (f). Pub. L. 112–144, § 614, substituted “Not later than
Subsec. (h). Pub. L. 112–144, § 615, added subsec. (h).
2007—Subsec. (a)(1)(B). Pub. L. 110–85, § 227, substituted “were to recur, which report under this subparagraph—” for “were to recur;” and added cls. (i) to (iii).
Subsecs. (f), (g). Pub. L. 110–85, § 226(a), added subsec. (f) and redesignated former subsec. (f) as (g).
1997—Subsec. (a). Pub. L. 105–115, § 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, § 213(a)(1)(B), substituted “manufacturer or importer” for “manufacturer, importer, or distributor”.
Subsec. (a)(7). Pub. L. 105–115, § 213(a)(1)(C), inserted “and” after semicolon at end.
Subsec. (a)(8). Pub. L. 105–115, § 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, § 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, § 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, § 213(c)(1)(B)(i), inserted “or” after comma at end.
Subsec. (b)(2)(B). Pub. L. 105–115, § 213(c)(1)(B)(ii), substituted period for “, or” at end.
Subsec. (b)(2)(C). Pub. L. 105–115, § 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, § 213(c)(2), added par. (5) and redesignated former par. (5) as (6).
Subsec. (d). Pub. L. 105–115, § 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, § 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, § 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, § 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, § 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, § 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, § 5(a)(2)(C), struck out “immediate” before “medical”.
1990—Subsec. (a)(6). Pub. L. 101–629, § 3(a)(1), added par. (6).
Subsecs. (b), (c). Pub. L. 101–629, § 2(a), added subsec. (b) and redesignated former subsec. (b) as (c).
Subsecs. (d), (e). Pub. L. 101–629, § 3(b)(1), added subsecs. (d) and (e).
Subsec. (f). Pub. L. 101–629, § 7, added subsec. (f).
Change Of Name
Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress,
Effective Date Of Amendment
Pub. L. 105–115, title II, § 211,
Amendment by section 213(a), (c) of Pub. L. 105–115 effective 90 days after
Pub. L. 102–300, § 2(b),
Pub. L. 102–300, § 5(b),
Pub. L. 101–629, § 2(c),
Pub. L. 101–629, § 3(a)(2),
Pub. L. 101–629, § 3(b)(3),
[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.]
Miscellaneous
Pub. L. 101–629, § 2(b),
Pub. L. 101–629, § 3(c),
[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.]
Pub. L. 101–629, § 2(d),
Pub. L. 101–629, § 2(e),
Pub. L. 101–629, § 2(f),