21 U.S.C. § 383 — Office of International Relations

(a) Establishment. This section creates an Office of International Relations inside the Department of Health and Human Services. (b) Agreements with foreign countries. To carry out the Office's work, the Secretary may make agreements with foreign countries. These agreements are meant to make it easier to trade devices between the United States and those countries, as long as the agreements still meet the requirements of this chapter. In these agreements, the Secretary must encourage other countries to mutually recognize (1) U.S. good manufacturing practice regulations for devices, and (2) other regulations and testing protocols the Secretary decides are appropriate. (c) Harmonizing regulatory requirements. This subsection has several parts. (1) The Secretary must support the U.S. Trade Representative, working with the Secretary of Commerce, in meetings with other countries about reducing regulatory burdens and harmonizing rules — but only if the Secretary decides that doing so still protects consumers the way this chapter intends. (2) The Secretary must support the Trade Representative and the Secretary of Commerce in working toward mutual recognition agreements with the European Union covering drugs, biological products, devices, foods, food additives, color additives, and good manufacturing practices. (3)(A) The Secretary must regularly join meetings with representatives of other governments to discuss and reach agreement on ways to harmonize regulatory requirements. (B) In doing this, the Secretary may take part in appropriate forums, including the International Medical Device Regulators Forum, and may: (i) give the forum guidance on its strategies, policies, direction, membership, and other activities; (ii) as appropriate, gather and consider comments from industry, academics, health care workers, and patient groups about the forum's work; and (iii) as appropriate, tell the public what the Secretary is doing in the forum and share related documents about the forum's strategies and policies with the public. (4) For devices, the Secretary may, when appropriate, make arrangements with other nations on ways to harmonize regulatory requirements, including for inspections and shared international labeling symbols. (5) None of paragraphs (1) through (4) apply to products defined in section 321(ff) of this title — a category this section does not itself define.