21 CFR 821.3 - Definitions.

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There is 1 rule appearing in the Federal Register for 21 CFR 821. View below or at eCFR (GPOAccess)
§ 821.3 Definitions.
The following definitions and terms apply to this part:
(a) Act means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq., as amended.
(b) Importer means the initial distributor of an imported device who is subject to a tracking order. “Importer” does not include anyone who only furthers the marketing, e.g., brokers, jobbers, or warehousers.
(c) Manufacturer means any person, including any importer, repacker and/or relabeler, who manufactures, prepares, propagates, compounds, assembles, or processes a device or engages in any of the activities described in § 807.3(d) of this chapter.
(d) Device failure means the failure of a device to perform or function as intended, including any deviations from the device's performance specifications or intended use.
(e) Serious adverse health consequences means any significant adverse experience related to a device, including device-related events which are life-threatening or which involve permanent or long-term injuries or illnesses.
(f) Device intended to be implanted in the human body for more than 1 year means a device that is intended to be placed into a surgically or naturally formed cavity of the human body for more than 1 year to continuously assist, restore, or replace the function of an organ system or structure of the human body throughout the useful life of the device. The term does not include a device that is intended and used only for temporary purposes or that is intended for explantation in 1 year or less.
(g) Life-supporting or life-sustaining device used outside a device user facility means a device which is essential, or yields information that is essential, to the restoration or continuation of a bodily function important to the continuation of human life that is intended for use outside a hospital, nursing home, ambulatory surgical facility, or diagnostic or outpatient treatment facility. Physicians' offices are not device user facilities and, therefore, devices used therein are subject to tracking if they otherwise satisfy the statutory and regulatory criteria.
(h) Distributor means any person who furthers the distribution of a device from the original place of manufacture to the person who makes delivery or sale to the ultimate user, i.e., the final or multiple distributor, but who does not repackage or otherwise change the container, wrapper, or labeling of the device or device package.
(i) Final distributor means any person who distributes a tracked device intended for use by a single patient over the useful life of the device to the patient. This term includes, but is not limited to, licensed practitioners, retail pharmacies, hospitals, and other types of device user facilities.
(j) Distributes means any distribution of a tracked device, including the charitable distribution of a tracked device. This term does not include the distribution of a device under an effective investigational device exemption in accordance with section 520(g) of the act and part 812 of this chapter or the distribution of a device for teaching, law enforcement, research, or analysis as specified in § 801.125 of this chapter.
(k) Multiple distributor means any device user facility, rental company, or any other entity that distributes a life-sustaining or life-supporting device intended for use by more than one patient over the useful life of the device.
(l) Licensed practitioner means a physician, dentist, or other health care practitioner licensed by the law of the State in which he or she practices to use or order the use of the tracked device.
(m) Any term defined in section 201 of the act shall have the same definition in this part.
[58 FR 43447, Aug. 16, 1993, as amended at 67 FR 5951, Feb. 8, 2002]

Title 21 published on 2013-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2013-09-24; vol. 78 # 185 - Tuesday, September 24, 2013
    1. 78 FR 58786 - Unique Device Identification System
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective December 23, 2013, except §§ 801.55, 830.10, 830.100, 830.110, 830.120, and 830.130 are effective October 24, 2013. The incorporation by reference of § 830.20 listed in the rule is approved by the Director of the Office of the Federal Register as of December 23, 2013. The incorporation by reference of §§ 830.10 and 830.100 listed in the rule is approved by the Director of the Office of the Federal Register as of October 24, 2013. Certain provisions have later compliance dates as discussed in section VII. B. “Compliance Dates.”
      21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830

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United States Code

Title 21 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 821 after this date.

  • 2013-09-24; vol. 78 # 185 - Tuesday, September 24, 2013
    1. 78 FR 58786 - Unique Device Identification System
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective December 23, 2013, except §§ 801.55, 830.10, 830.100, 830.110, 830.120, and 830.130 are effective October 24, 2013. The incorporation by reference of § 830.20 listed in the rule is approved by the Director of the Office of the Federal Register as of December 23, 2013. The incorporation by reference of §§ 830.10 and 830.100 listed in the rule is approved by the Director of the Office of the Federal Register as of October 24, 2013. Certain provisions have later compliance dates as discussed in section VII. B. “Compliance Dates.”
      21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830