21 CFR 803.58 - Foreign manufacturers.

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§ 803.58 Foreign manufacturers.
(a) Every foreign manufacturer whose devices are distributed in the United States shall designate a U.S. agent to be responsible for reporting in accordance with § 807.40 of this chapter. The U.S. designated agent accepts responsibility for the duties that such designation entails. Upon the effective date of this regulation, foreign manufacturers shall inform FDA, by letter, of the name and address of the U.S. agent designated under this section and § 807.40 of this chapter, and shall update this information as necessary. Such updated information shall be submitted to FDA, within 5 days of a change in the designated agent information.
(b) U.S.-designated agents of foreign manufacturers are required to:
(1) Report to FDA in accordance with §§ 803.50, 803.52, 803.53, 803.55, and 803.56;
(2) Conduct, or obtain from the foreign manufacturer the necessary information regarding, the investigation and evaluation of the event to comport with the requirements of § 803.50;
(3) Forward MDR complaints to the foreign manufacturer and maintain documentation of this requirement;
(4) Maintain complaint files in accordance with § 803.18; and
(5) Register, list, and submit premarket notifications in accordance with part 807 of this chapter.
Effective Date Note:
At 61 FR 38347, July 23, 1996, § 803.58 was stayed indefinitely. At 73 FR 33695, June 13, 2008, § 803.58(b)(1) was amended, but the amendment could not be incorporated because the section is stayed.

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.

  • 2014-02-14; vol. 79 # 31 - Friday, February 14, 2014
    1. 79 FR 8832 - Medical Device Reporting: Electronic Submission Requirements
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This final rule is effective August 14, 2015 (see also section IX of this document).
      21 CFR Part 803

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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 803 after this date.

  • 2014-02-14; vol. 79 # 31 - Friday, February 14, 2014
    1. 79 FR 8832 - Medical Device Reporting: Electronic Submission Requirements
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This final rule is effective August 14, 2015 (see also section IX of this document).
      21 CFR Part 803