21 CFR 801.1 - Medical devices; name and place of business of manufacturer, packer or distributor.

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§ 801.1 Medical devices; name and place of business of manufacturer, packer or distributor.
(a) The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.
(b) The requirement for declaration of the name of the manufacturer, packer, or distributor shall be deemed to be satisfied, in the case of a corporation, only by the actual corporate name which may be preceded or followed by the name of the particular division of the corporation. Abbreviations for “Company,” “Incorporated,” etc., may be used and “The” may be omitted. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used.
(c) Where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such device; such as, “Manufactured for ___”, “Distributed by _____”, or any other wording that expresses the facts.
(d) The statement of the place of business shall include the street address, city, State, and Zip Code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. The requirement for inclusion of the ZIP Code shall apply only to consumer commodity labels developed or revised after the effective date of this section. In the case of nonconsumer packages, the ZIP Code shall appear on either the label or the labeling (including the invoice).
(e) If a person manufactures, packs, or distributes a device at a place other than his principal place of business, the label may state the principal place of business in lieu of the actual place where such device was manufactured or packed or is to be distributed, unless such statement would be misleading.

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 801 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