21 C.F.R. § 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. (1) Report to FDA in accordance with §§ 803.50, 803.52, 803.53, and 803.56;
2. (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. (3) Forward MDR complaints to the foreign manufacturer and maintain documentation of this requirement;
4. (4) Maintain complaint files in accordance with § 803.18; and
5. (5) Register, list, and submit premarket notifications in accordance with part 807 of this chapter.
  Effective Date Note:At 79 FR 8846, Feb. 14, 2014, part 803 was revised. At 79 FR 8855, Feb. 14, 2014, § 803.58 was stayed indefinitely.