PRIA, Government Policy, Made Personal

Summary

Creates an Office of International Relations inside the Department of Health and Human Services. The Secretary can make agreements with other countries to help trade medical devices with the United States. Those agreements should promote mutual acceptance of good manufacturing practice rules under section 360j(f) and of other rules and testing methods the Secretary finds useful. The Secretary must help the Office of the United States Trade Representative, with the Secretary of Commerce, in talks to reduce regulatory burdens and align rules so long as consumer protections stay the same. The Secretary must work toward mutual recognition agreements with the European Union on drugs, biological products, devices, foods, food additives, color additives, and good manufacturing practices. The Secretary will meet with foreign governments, join groups like the International Medical Device Regulators Forum, give guidance to those groups, gather outside comments, and share information with the public. For devices, the Secretary can make arrangements on inspections and common international labeling symbols. Paragraphs (1)–(4) do not apply to products in section 321(ff).

Title 21, §383

Food and Drugs, Source: USLM XML via OLRC

(a)Establishment

There is established in the Department of Health and Human Services an Office of International Relations.

(b)Agreements with foreign countries

In carrying out the functions of the office under subsection (a), the Secretary may enter into agreements with foreign countries to facilitate commerce in devices between the United States and such countries consistent with the requirements of this chapter. In such agreements, the Secretary shall encourage the mutual recognition of— (1)

(2)other regulations and testing protocols as the Secretary determines to be appropriate.

(c)Harmonizing regulatory requirements

(1)The Secretary shall support the Office of the United States Trade Representative, in consultation with the Secretary of Commerce, in meetings with representatives of other countries to discuss methods and approaches to reduce the burden of regulation and harmonize regulatory requirements if the Secretary determines that such harmonization continues consumer protections consistent with the purposes of this chapter.

(2)The Secretary shall support the Office of the United States Trade Representative, in consultation with the Secretary of Commerce, in efforts to move toward the acceptance of mutual recognition agreements relating to the regulation of drugs, biological products, devices, foods, food additives, and color additives, and the regulation of good manufacturing practices, between the European Union and the United States.

(3)(A)The Secretary shall regularly participate in meetings with representatives of other foreign governments to discuss and reach agreement on methods and approaches to harmonize regulatory requirements.

(B)In carrying out subparagraph (A), the Secretary may participate in appropriate fora, including the International Medical Device Regulators Forum, and may—

(i)provide guidance to such fora on strategies, policies, directions, membership, and other activities of a forum as appropriate;

(ii)to the extent appropriate, solicit, review, and consider comments from industry, academia, health care professionals, and patient groups regarding the activities of such fora; and

(iii)to the extent appropriate, inform the public of the Secretary’s activities within such fora, and share with the public any documentation relating to a forum’s strategies, policies, and other activities of such fora.

(4)With respect to devices, the Secretary may, when appropriate, enter into arrangements with nations regarding methods and approaches to harmonizing regulatory requirements for activities, including inspections and common international labeling symbols.

(5)Paragraphs (1) through (4) shall not apply with respect to products defined in section 321(ff) of this title.

Notes & Related Subsidiaries

Editorial Notes

Amendments

2012—Subsec. (c)(3). Pub. L. 112–144, § 610, designated existing provisions as subpar. (A) and added subpar. (B). Subsec. (c)(4). Pub. L. 112–144, § 609, amended par. (4) generally. Prior to amendment, par. (4) read as follows: “The Secretary shall, not later than 180 days after November 21, 1997, make public a plan that establishes a framework for achieving mutual recognition of good manufacturing practices inspections.” 1997—Subsec. (c). Pub. L. 105–115 added subsec. (c).

Statutory Notes and Related Subsidiaries

Effective Date

of 1997 AmendmentAmendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title. Report on Activities of Office of International Relations Pub. L. 101–629, § 15(b), Nov. 28, 1990, 104 Stat. 4525, directed Secretary of Health and Human Services, not later than 2 years after Nov. 28, 1990, to prepare and submit to the appropriate committees of Congress a report on the activities of the Office of International Relations under 21 U.S.C. 383.

§383 Office of International Relations