§360l. Postmarket surveillance — Inbound Citations

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

• 21 U.S.C. § 331(q)(1)(C)

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  (C) to comply with a requirement under section 360l or 387m of this title.
• 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. § 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.
• 21 U.S.C. § 360i(i)(1)

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  (1) In order to provide timely and reliable information on the safety and effectiveness of devices approved under section 360e of this title, cleared under section 360(k) of this title, or classified under section 360c(f)(2) of this title, including responses to adverse events and malfunctions, and to advance the objectives of part 803 of title 21, Code of Federal Regulations (or successor regulations), and advance the objectives of, and evaluate innovative new methods of compliance with, this section and section 360l of this title, the Secretary shall, within one year of August 18, 2017, initiate one or more pilot projects for voluntary participation by a manufacturer or manufacturers of a device or device type, or continue existing projects, in accordance with paragraph (3), that—

  (A) are designed to efficiently generate reliable and timely safety and active surveillance data for use by the Secretary or manufacturers of the devices that are involved in the pilot project;

  (B) inform the development of methods, systems, data criteria, and programs that could be used to support safety and active surveillance activities for devices included or not included in such project;

  (C) may be designed and conducted in coordination with a comprehensive system for evaluating medical device technology that operates under a governing board with appropriate representation of stakeholders, including patient groups and device manufacturers;

  (D) use electronic health data including claims data, patient survey data, or any other data, as the Secretary determines appropriate; and

  (E) prioritize devices and device types that meet one or more of the following criteria:

  (i) Devices and device types for which the collection and analysis of real world evidence regarding a device’s safety and effectiveness is likely to advance public health.

  (ii) Devices and device types that are widely used.

  (iii) Devices and device types, the failure of which has significant health consequences.

  (iv) Devices and device types for which the Secretary—

  (I) has received public recommendations in accordance with paragraph (2)(B); and

  (II) has determined to meet one or more of the criteria under clause (i), (ii), or (iii) and is appropriate for such a pilot project.
• 21 U.S.C. § 360i(i)(5)

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  (5) The participation of a manufacturer in pilot projects under this subsection or a project continued or expanded under paragraph (3) shall not affect the eligibility of such manufacturer to participate in any quarterly reporting program with respect to devices carried out under this section 360i³ or section 360l of this title. The Secretary may determine that, for a specified time period to be determined by the Secretary, a manufacturer’s participation in a pilot project under this subsection or a project continued or expanded under paragraph (3) may meet the applicable requirements of this section or section 360l of this title, if—

  (A) the project has demonstrated success in capturing relevant adverse event information; and

  (B) the Secretary has established procedures for making adverse event and safety information collected from such project public, to the extent possible.