[§803. Repealed. Pub. L. 95–137, § 1(b), Oct. 18, 1977, 91 Stat. 1169 — repealed] — Inbound Citations

Citations to 21 U.S.C. § 803 as a whole

• 21 U.S.C. § 360i(a)(1)(B)(i)

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  (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;
• 21 U.S.C. § 360i(a)(1)(B)(iii)

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  (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)¹
• 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.