§360i. Records and reports on devices — Inbound Citations

Implementing Regulations (Code of Federal Regulations)

Statutory authority for 23 regulations in the Code of Federal Regulations.

• 21 C.F.R. § 900.1 — Scope.

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• 21 C.F.R. § 900.10 — Applicability.

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• 21 C.F.R. § 900.11 — Requirements for certification.

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• 21 C.F.R. § 900.12 — Quality standards.

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• 21 C.F.R. § 900.13 — Revocation of accreditation and revocation of accreditation body approval.

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• 21 C.F.R. § 900.14 — Suspension or revocation of certificates.

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• 21 C.F.R. § 900.15 — Appeals of adverse accreditation or reaccreditation decisions that preclude certification or recertification.

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• 21 C.F.R. § 900.16 — Appeals of denials of certification.

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• 21 C.F.R. § 900.17 — [Reserved]

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• 21 C.F.R. § 900.18 — Alternative requirements for § 900.12 quality standards.

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• 21 C.F.R. § 900.2 — Definitions.

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• 21 C.F.R. § 900.20 — Scope.

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• 21 C.F.R. § 900.21 — Application for approval as a certification agency.

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• 21 C.F.R. § 900.22 — Standards for certification agencies.

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• 21 C.F.R. § 900.23 — Evaluation.

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• 21 C.F.R. § 900.24 — Withdrawal of approval.

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• 21 C.F.R. § 900.25 — Hearings and appeals.

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• 21 C.F.R. § 900.3 — Application for approval as an accreditation body.

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• 21 C.F.R. § 900.4 — Standards for accreditation bodies.

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• 21 C.F.R. § 900.5 — Evaluation.

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• 21 C.F.R. § 900.6 — Withdrawal of approval.

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• 21 C.F.R. § 900.7 — Hearings.

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• 21 C.F.R. § 900.8-900.9 — [Reserved]

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Code of Federal Regulations Citations

Cited by 1 regulation in the Code of Federal Regulations.

• 21 C.F.R. § 803.9(c)(1) — What information from the reports do we disclose to the public?

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  (1) An action brought to enforce section 301(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(q)), including the failure or refusal to furnish material or information required by section 519 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i));

Citations to 21 U.S.C. § 360i as a whole

• 21 U.S.C. § 331(e)

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  (e) The refusal to permit access to or copying of any record as required by section 350a, 350c, 350f(j), 350e, 354, 360bbb–3, 364a, 373, 374(a), 379aa, or 379aa–1 of this title; or the failure to establish or maintain any record, or make any report, required under section 350a, 350c(b), 350f, 350e, 354, 355(i) or (k), 360b(a)(4)(C), 360b(j), (l) or (m), 360ccc–1(i), 360e(f), 360i, 360bbb–3, 364a, 364g, 379aa, 379aa–1, 387i, or 387t of this title or the refusal to permit access to or verification or copying of any such required record; or the violation of any recordkeeping requirement under section 2223² of this title (except when such violation is committed by a farm).

• 21 U.S.C. § 331(j)

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  (j) The using by any person to his own advantage, or revealing, other than to the Secretary or officers or employees of the Department, or to the courts when relevant in any judicial proceeding under this chapter, any information acquired under authority of section 344, 348, 350a, 350c, 355, 360, 360b, 360c, 360d, 360e, 360f, 360h, 360i, 360j, 360ccc, 360ccc–1, 360ccc–2, 374, 379, 379e, 387d, 387e, 387f, 387g, 387h, 387i, or 387t(b) of this title concerning any method or process which as a trade secret is entitled to protection; or the violating of section 346a(i)(2) of this title or any regulation issued under that section..¹This paragraph does not authorize the withholding of information from either House of Congress or from, to the extent of matter within its jurisdiction, any committee or subcommittee of such committee or any joint committee of Congress or any subcommittee of such joint committee.

• 21 U.S.C. § 331(q)(1)(B)

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  (B) to furnish any notification or other material or information required by or under section 360i, 360j(g), 387d, 387i, or 387t of this title; or

• 21 U.S.C. § 352(t)

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  (t) If it is a device and there was a failure or refusal (1) to comply with any requirement prescribed under section 360h of this title respecting the device, (2) to furnish any material or information required by or under section 360i of this title respecting the device, or (3) to comply with a requirement under section 360l of this title.

• 21 U.S.C. § 360c(a)(1)(A)(i)

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  (i) A device for which the controls authorized by or under section 351, 352, 360, 360f, 360h, 360i, or 360j of this title or any combination of such sections are sufficient to provide reasonable assurance of the safety and effectiveness of the device.

• 21 U.S.C. § 360c(c)(2)(B)

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  (B) A recommendation of a panel for the classification of a device in class I shall include a recommendation as to whether the device should be exempted from the requirements of section 360, 360i, or 360j(f) of this title.

• 21 U.S.C. § 360c(d)(2)(A)

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  (A) A regulation under paragraph (1) classifying a device in class I shall prescribe which, if any, of the requirements of section 360, 360i, or 360j(f) of this title shall not apply to the device. A regulation which makes a requirement of section 360, 360i, or 360j(f) of this title inapplicable to a device shall be accompanied by a statement of the reasons of the Secretary for making such requirement inapplicable.

• 21 U.S.C. § 360c(f)(3)(B)(ii)

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  (ii) The requirements of paragraphs (1) and (2) of subsection (c) (relating to opportunities for submission of data and views and recommendations respecting priorities and exemptions from sections 360, 360i, and 360j(f) of this title) shall apply with respect to consideration by panels of petitions submitted under subparagraph (A).

• 21 U.S.C. § 360c(f)(3)(C)(ii)

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  (ii) The requirements of paragraphs (1) and (2)(A) of subsection (d) (relating to publication of recommendations, opportunity for submission of comments, and exemption from sections 360, 360i, and 360j(f) of this title) shall apply with respect to action by the Secretary on petitions submitted under subparagraph (A).

• 21 U.S.C. § 360c(f)(4)

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  (4) If a manufacturer reports to the Secretary under section 360(k) of this title that a device is substantially equivalent to another device—

  (A) which the Secretary has classified as a class III device under subsection (b),

  (B) which was introduced or delivered for introduction into interstate commerce for commercial distribution before December 1, 1990, and

  (C) for which no final regulation requiring premarket approval has been promulgated under section 360e(b) of this title,

  the manufacturer shall certify to the Secretary that the manufacturer has conducted a reasonable search of all information known or otherwise available to the manufacturer respecting such other device and has included in the report under section 360(k) of this title a summary of and a citation to all adverse safety and effectiveness data respecting such other device and respecting the device for which the section 360(k) report is being made and which has not been submitted to the Secretary under section 360i of this title. The Secretary may require the manufacturer to submit the adverse safety and effectiveness data described in the report.

• 21 U.S.C. § 360c(h)

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  (h) For purposes of this section and sections 351, 360, 360d, 360e, 360f, 360i, and 360j of this title

  (1) a reference to “general controls” is a reference to the controls authorized by or under sections 351, 352, 360, 360f, 360h, 360i, and 360j of this title,

  (2) a reference to “class I”, “class II”, or “class III” is a reference to a class of medical devices described in subparagraph (A), (B), or (C) of subsection (a)(1), and

  (3) a reference to a “panel under section 360c of this title” is a reference to a panel established or authorized to be used under this section.

• 21 U.S.C. § 360c(h)(1)

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  (1) a reference to “general controls” is a reference to the controls authorized by or under sections 351, 352, 360, 360f, 360h, 360i, and 360j of this title,

• 21 U.S.C. § 360e(i)(1)

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  (1) Before December 1, 1995, the Secretary shall by order require manufacturers of devices, which were introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, and which are subject to revision of classification under paragraph (2), to submit to the Secretary a summary of and citation to any information known or otherwise available to the manufacturer respecting such devices, including adverse safety or effectiveness information which has not been submitted under section 360i of this title. The Secretary may require the manufacturer to submit the adverse safety or effectiveness data for which a summary and citation were submitted, if such data are available to the manufacturer.

• 21 U.S.C. § 360g(f)

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  (f) To facilitate judicial review under this section or under any other provision of law of a regulation or order issued under section 360c, 360d, 360e, 360f, 360h, 360i, 360j, or 360k of this title each such regulation or order shall contain a statement of the reasons for its issuance and the basis, in the record of the proceedings held in connection with its issuance, for its issuance.

• 21 U.S.C. § 360j(a)

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  (a) Any requirement authorized by or under section 351, 352, 360, or 360i of this title applicable to a device intended for human use shall apply to such device until the applicability of the requirement to the device has been changed by action taken under section 360c, 360d, or 360e of this title or under subsection (g) of this section, and any requirement established by or under section 351, 352, 360, or 360i of this title which is inconsistent with a requirement imposed on such device under section 360d or 360e of this title or under subsection (g) of this section shall not apply to such device.

• 21 U.S.C. § 360j(c)

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  (c) Any information reported to or otherwise obtained by the Secretary or his representative under section 360c, 360d, 360e, 360f, 360h, 360i, or 374 of this title or under subsection (f) or (g) of this section which is exempt from disclosure pursuant to subsection (a) of section 552 of title 5 by reason of subsection (b)(4) of such section shall be considered confidential and shall not be disclosed and may not be used by the Secretary as the basis for the reclassification of a device from class III to class II or class I or as the basis for the establishment or amendment of a performance standard under section 360d of this title for a device reclassified from class III to class II, except (1) in accordance with subsection (h), and (2) that such information may be disclosed to other officers or employees concerned with carrying out this chapter or when relevant in any proceeding under this chapter (other than section 360c or 360d of this title).

• 21 U.S.C. § 360j(d)

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  (d) Each notice of proposed rulemaking under section 360c, 360d, 360e, 360f, 360h, or 360i of this title, or under this section, any other notice which is published in the Federal Register with respect to any other action taken under any such section and which states the reasons for such action, and each publication of findings required to be made in connection with rulemaking under any such section shall set forth—

  (1) the manner in which interested persons may examine data and other information on which the notice or findings is based, and

  (2) the period within which interested persons may present their comments on the notice or findings (including the need therefor) orally or in writing, which period shall be at least sixty days but may not exceed ninety days unless the time is extended by the Secretary by a notice published in the Federal Register stating good cause therefor.

• 21 U.S.C. § 360j(g)(2)(A)

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  (A) The Secretary shall, within the one hundred and twenty-day period beginning on May 28, 1976, by regulation prescribe procedures and conditions under which devices intended for human use may upon application be granted an exemption from the requirements of section 352, 360, 360d, 360e, 360f, 360i, or 379e of this title or subsection (e) or (f) of this section or from any combination of such requirements to permit the investigational use of such devices by experts qualified by scientific training and experience to investigate the safety and effectiveness of such devices.

• 21 U.S.C. § 360j(l)(5)(A)

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  (A) Before December 1, 1991, the Secretary shall by order require manufacturers of devices described in paragraph (1), which are subject to revision of classification under subparagraph (B), to submit to the Secretary a summary of and citation to any information known or otherwise available to the manufacturers respecting the devices, including adverse safety or effectiveness information which has not been submitted under section 360i of this title. The Secretary may require a manufacturer to submit the adverse safety or effectiveness data for which a summary and citation were submitted, if such data are available to the manufacturer.

• 21 U.S.C. § 374(a)(1)

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  (1) For purposes of enforcement of this chapter, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (A) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, tobacco products, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, tobacco products, or cosmetics in interstate commerce; and (B) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein. In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in section 350c of this title, when the standard for records inspection under paragraph (1) or (2) of section 350c(a) of this title applies, subject to the limitations established in section 350c(d) of this title. In the case of a facility (as defined in section 364 of this title) that manufactures or processes cosmetic products, the inspection shall extend to all records and other information described in sections 364a, 364b, and 364f of this title, when the standard for records inspection under such section applies. In the case of any factory, warehouse, establishment, or consulting laboratory in which prescription drugs, nonprescription drugs intended for human use, devices, or tobacco products are manufactured, processed, packed, or held, the inspection shall extend to all things therein (including records, files, papers, processes, controls, and facilities) bearing on whether prescription drugs, nonprescription drugs intended for human use, devices, or tobacco products which are adulterated or misbranded within the meaning of this chapter, or which may not be manufactured, introduced into interstate commerce, or sold, or offered for sale by reason of any provision of this chapter, have been or are being manufactured, processed, packed, transported, or held in any such place, or otherwise bearing on violation of this chapter. No inspection authorized by the preceding sentence or by paragraph (3) shall extend to financial data, sales data other than shipment data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this chapter), and research data (other than data relating to new drugs, antibiotic drugs, devices, and tobacco products and subject to reporting and inspection under regulations lawfully issued pursuant to section 355(i) or (k) of this title, section 360i of this title, section 360j(g) of this title, or subchapter IX and data relating to other drugs, devices, or tobacco products which in the case of a new drug would be subject to reporting or inspection under lawful regulations issued pursuant to section 355(j) of this title). A separate notice shall be given for each such inspection, but a notice shall not be required for each entry made during the period covered by the inspection. Each such inspection shall be commenced and completed with reasonable promptness.

• 21 U.S.C. § 374(e)

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  (e) Every person required under section 360i or 360j(g) of this title to maintain records and every person who is in charge or custody of such records shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to, and to copy and verify, such records.

Citations to §360i(a)

• 21 U.S.C. § 333(f)(1)(B)(i)

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  (i) to any person who violates the requirements of section 360i(a) or 360j(f) of this title unless such violation constitutes (I) a significant or knowing departure from such requirements, or (II) a risk to public health,

• 21 U.S.C. § 360e(e)(1)(D)

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  (D) that the applicant (i) has failed to establish a system for maintaining records, or has repeatedly or deliberately failed to maintain records or to make reports, required by an applicable regulation under section 360i(a) of this title, (ii) has refused to permit access to, or copying or verification of, such records as required by section 374 of this title, or (iii) has not complied with the requirements of section 360 of this title;

Citations to §360i(b)(1)

• 21 U.S.C. § 360i(b)(5)(A)

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  (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.

• 21 U.S.C. § 360i(b)(5)(B)

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  (B) During the period of planning the program under subparagraph (A), paragraphs (1) through (4) continue to apply.

• 21 U.S.C. § 360i(b)(5)(C)

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  (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.

• 21 U.S.C. § 360i(b)(5)(D)

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  (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).

Citations to §360i(b)(2)

• 21 U.S.C. § 360i(b)(5)(A)

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  (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.

• 21 U.S.C. § 360i(b)(5)(B)

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  (B) During the period of planning the program under subparagraph (A), paragraphs (1) through (4) continue to apply.

• 21 U.S.C. § 360i(b)(5)(C)

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  (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.

• 21 U.S.C. § 360i(b)(5)(D)

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  (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).

Citations to §360i(b)(3)

• 21 U.S.C. § 360i(b)(5)(A)

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  (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.

• 21 U.S.C. § 360i(b)(5)(B)

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  (B) During the period of planning the program under subparagraph (A), paragraphs (1) through (4) continue to apply.

• 21 U.S.C. § 360i(b)(5)(C)

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  (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.

• 21 U.S.C. § 360i(b)(5)(D)

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  (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).

Citations to §360i(b)(4)

• 21 U.S.C. § 360i(b)(5)(A)

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  (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.

• 21 U.S.C. § 360i(b)(5)(B)

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  (B) During the period of planning the program under subparagraph (A), paragraphs (1) through (4) continue to apply.

• 21 U.S.C. § 360i(b)(5)(C)

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  (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.

• 21 U.S.C. § 360i(b)(5)(D)

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  (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).

Citations to §360i(e)

• 21 U.S.C. § 333(f)(1)(B)(ii)

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  (ii) to any person who commits minor violations of section 360i(e) or 360i(g) of this title (only with respect to correction reports) if such person demonstrates substantial compliance with such section, or

• 21 U.S.C. § 360j(j)

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  (j) Except as provided in section 360i(e) of this title, no regulation under this chapter may impose on a type or class of device requirements for the traceability of such type or class of device unless such requirements are necessary to assure the protection of the public health.

Citations to §360i(g)

• 21 U.S.C. § 333(f)(1)(B)(ii)

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  (ii) to any person who commits minor violations of section 360i(e) or 360i(g) of this title (only with respect to correction reports) if such person demonstrates substantial compliance with such section, or

• 21 U.S.C. § 360h–1(c)(2)

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  (2) the correction or removal from the market of a device at the initiative of the manufacturer or importer of the device that is required to be reported to the Secretary under section 360i(g) of this title.

Citations to §360i(h)

• 21 U.S.C. § 360e–3(g)(4)

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  (4) the authority of the Secretary with respect to postmarket surveillance under sections 360i(h) and 360l of this title.

Citations to §360i(i)(1)(A)

• 21 U.S.C. § 360i(i)(3)(A)

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  (A) to ensure such projects meet the requirements of subparagraphs (A) through (E) of paragraph (1); and

• 21 U.S.C. § 360i(i)(4)(A)

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  (A) The Secretary may carry out a pilot project meeting the criteria specified in subparagraphs (A) through (E) of paragraph (1) or a project continued or expanded under paragraph (3) by entering into contracts, cooperative agreements, grants, or other appropriate agreements with public or private entities that have a significant presence in the United States and meet the following conditions:

  (i) If such an entity is a component of another organization, the entity and the organization have established an agreement under which appropriate security measures are implemented to maintain the confidentiality and privacy of the data described in paragraph (1)(D) and such agreement ensures that the entity will not make an unauthorized disclosure of such data to the other components of the organization in breach of requirements with respect to confidentiality and privacy of such data established under such security measures.

  (ii) In the case of the termination or nonrenewal of such a contract, cooperative agreement, grant, or other appropriate agreement, the entity or entities involved shall comply with each of the following:

  (I) The entity or entities shall continue to comply with the requirements with respect to confidentiality and privacy referred to in clause (i) with respect to all data disclosed to the entity under such an agreement.

  (II) The entity or entities shall return any data disclosed to such entity pursuant to this subsection and to which it would not otherwise have access or, if returning such data is not practicable, destroy the data.

  (iii) The entity or entities shall have one or more qualifications with respect to—

  (I) research, statistical, epidemiologic, or clinical capability and expertise to conduct and complete the activities under this subsection, including the capability and expertise to provide the Secretary access to de-identified data consistent with the requirements of this subsection;

  (II) an information technology infrastructure to support electronic data and operational standards to provide security for such data, as appropriate;

  (III) experience with, and expertise on, the development of research on, and surveillance of, device safety and effectiveness using electronic health data; or

  (IV) such other expertise which the Secretary determines necessary to carry out such a project.

Citations to §360i(i)(1)(B)

• 21 U.S.C. § 360i(i)(3)(A)

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  (A) to ensure such projects meet the requirements of subparagraphs (A) through (E) of paragraph (1); and

• 21 U.S.C. § 360i(i)(4)(A)

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  (A) The Secretary may carry out a pilot project meeting the criteria specified in subparagraphs (A) through (E) of paragraph (1) or a project continued or expanded under paragraph (3) by entering into contracts, cooperative agreements, grants, or other appropriate agreements with public or private entities that have a significant presence in the United States and meet the following conditions:

  (i) If such an entity is a component of another organization, the entity and the organization have established an agreement under which appropriate security measures are implemented to maintain the confidentiality and privacy of the data described in paragraph (1)(D) and such agreement ensures that the entity will not make an unauthorized disclosure of such data to the other components of the organization in breach of requirements with respect to confidentiality and privacy of such data established under such security measures.

  (ii) In the case of the termination or nonrenewal of such a contract, cooperative agreement, grant, or other appropriate agreement, the entity or entities involved shall comply with each of the following:

  (I) The entity or entities shall continue to comply with the requirements with respect to confidentiality and privacy referred to in clause (i) with respect to all data disclosed to the entity under such an agreement.

  (II) The entity or entities shall return any data disclosed to such entity pursuant to this subsection and to which it would not otherwise have access or, if returning such data is not practicable, destroy the data.

  (iii) The entity or entities shall have one or more qualifications with respect to—

  (I) research, statistical, epidemiologic, or clinical capability and expertise to conduct and complete the activities under this subsection, including the capability and expertise to provide the Secretary access to de-identified data consistent with the requirements of this subsection;

  (II) an information technology infrastructure to support electronic data and operational standards to provide security for such data, as appropriate;

  (III) experience with, and expertise on, the development of research on, and surveillance of, device safety and effectiveness using electronic health data; or

  (IV) such other expertise which the Secretary determines necessary to carry out such a project.

Citations to §360i(i)(1)(C)

• 21 U.S.C. § 360i(i)(3)(A)

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  (A) to ensure such projects meet the requirements of subparagraphs (A) through (E) of paragraph (1); and

• 21 U.S.C. § 360i(i)(4)(A)

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  (A) The Secretary may carry out a pilot project meeting the criteria specified in subparagraphs (A) through (E) of paragraph (1) or a project continued or expanded under paragraph (3) by entering into contracts, cooperative agreements, grants, or other appropriate agreements with public or private entities that have a significant presence in the United States and meet the following conditions:

  (i) If such an entity is a component of another organization, the entity and the organization have established an agreement under which appropriate security measures are implemented to maintain the confidentiality and privacy of the data described in paragraph (1)(D) and such agreement ensures that the entity will not make an unauthorized disclosure of such data to the other components of the organization in breach of requirements with respect to confidentiality and privacy of such data established under such security measures.

  (ii) In the case of the termination or nonrenewal of such a contract, cooperative agreement, grant, or other appropriate agreement, the entity or entities involved shall comply with each of the following:

  (I) The entity or entities shall continue to comply with the requirements with respect to confidentiality and privacy referred to in clause (i) with respect to all data disclosed to the entity under such an agreement.

  (II) The entity or entities shall return any data disclosed to such entity pursuant to this subsection and to which it would not otherwise have access or, if returning such data is not practicable, destroy the data.

  (iii) The entity or entities shall have one or more qualifications with respect to—

  (I) research, statistical, epidemiologic, or clinical capability and expertise to conduct and complete the activities under this subsection, including the capability and expertise to provide the Secretary access to de-identified data consistent with the requirements of this subsection;

  (II) an information technology infrastructure to support electronic data and operational standards to provide security for such data, as appropriate;

  (III) experience with, and expertise on, the development of research on, and surveillance of, device safety and effectiveness using electronic health data; or

  (IV) such other expertise which the Secretary determines necessary to carry out such a project.

Citations to §360i(i)(1)(D)

• 21 U.S.C. § 360i(i)(3)(A)

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  (A) to ensure such projects meet the requirements of subparagraphs (A) through (E) of paragraph (1); and

• 21 U.S.C. § 360i(i)(4)(A)

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  (A) The Secretary may carry out a pilot project meeting the criteria specified in subparagraphs (A) through (E) of paragraph (1) or a project continued or expanded under paragraph (3) by entering into contracts, cooperative agreements, grants, or other appropriate agreements with public or private entities that have a significant presence in the United States and meet the following conditions:

  (i) If such an entity is a component of another organization, the entity and the organization have established an agreement under which appropriate security measures are implemented to maintain the confidentiality and privacy of the data described in paragraph (1)(D) and such agreement ensures that the entity will not make an unauthorized disclosure of such data to the other components of the organization in breach of requirements with respect to confidentiality and privacy of such data established under such security measures.

  (ii) In the case of the termination or nonrenewal of such a contract, cooperative agreement, grant, or other appropriate agreement, the entity or entities involved shall comply with each of the following:

  (I) The entity or entities shall continue to comply with the requirements with respect to confidentiality and privacy referred to in clause (i) with respect to all data disclosed to the entity under such an agreement.

  (II) The entity or entities shall return any data disclosed to such entity pursuant to this subsection and to which it would not otherwise have access or, if returning such data is not practicable, destroy the data.

  (iii) The entity or entities shall have one or more qualifications with respect to—

  (I) research, statistical, epidemiologic, or clinical capability and expertise to conduct and complete the activities under this subsection, including the capability and expertise to provide the Secretary access to de-identified data consistent with the requirements of this subsection;

  (II) an information technology infrastructure to support electronic data and operational standards to provide security for such data, as appropriate;

  (III) experience with, and expertise on, the development of research on, and surveillance of, device safety and effectiveness using electronic health data; or

  (IV) such other expertise which the Secretary determines necessary to carry out such a project.

Citations to §360i(i)(1)(E)

• 21 U.S.C. § 360i(i)(3)(A)

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  (A) to ensure such projects meet the requirements of subparagraphs (A) through (E) of paragraph (1); and

• 21 U.S.C. § 360i(i)(4)(A)

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  (A) The Secretary may carry out a pilot project meeting the criteria specified in subparagraphs (A) through (E) of paragraph (1) or a project continued or expanded under paragraph (3) by entering into contracts, cooperative agreements, grants, or other appropriate agreements with public or private entities that have a significant presence in the United States and meet the following conditions:

  (i) If such an entity is a component of another organization, the entity and the organization have established an agreement under which appropriate security measures are implemented to maintain the confidentiality and privacy of the data described in paragraph (1)(D) and such agreement ensures that the entity will not make an unauthorized disclosure of such data to the other components of the organization in breach of requirements with respect to confidentiality and privacy of such data established under such security measures.

  (ii) In the case of the termination or nonrenewal of such a contract, cooperative agreement, grant, or other appropriate agreement, the entity or entities involved shall comply with each of the following:

  (I) The entity or entities shall continue to comply with the requirements with respect to confidentiality and privacy referred to in clause (i) with respect to all data disclosed to the entity under such an agreement.

  (II) The entity or entities shall return any data disclosed to such entity pursuant to this subsection and to which it would not otherwise have access or, if returning such data is not practicable, destroy the data.

  (iii) The entity or entities shall have one or more qualifications with respect to—

  (I) research, statistical, epidemiologic, or clinical capability and expertise to conduct and complete the activities under this subsection, including the capability and expertise to provide the Secretary access to de-identified data consistent with the requirements of this subsection;

  (II) an information technology infrastructure to support electronic data and operational standards to provide security for such data, as appropriate;

  (III) experience with, and expertise on, the development of research on, and surveillance of, device safety and effectiveness using electronic health data; or

  (IV) such other expertise which the Secretary determines necessary to carry out such a project.