Medical Device Link.

Originally Published EMDM May/June 2002

INDUSTRY NEWS

A new US FDA regulation requiring all foreign manufacturers of medical devices to identify and appoint a US agent was to be enforced beginning 26 April. The US agent must be a resident citizen of the United States and is mandated to act as the foreign manufacturer's representative for purposes of regulatory contacts with US FDA. All foreign manufacturers of medical devices, in vitro diagnostic products, human drugs, animal drugs, and biological products that currently export or plan to export their products to the United States are affected by this new regulation.

US FDA published the regulation (21 CFR 807.40) on 27 November 2001, and it went into effect on 11 February of this year. While the regulation has just recently been made final, US FDA first published a requirement to appoint a US agent shortly after the implementation of the Food and Drug Administration Modernization Act of 1997. The original requirement—which was directed at medical device manufacturers—was placed on hold pending the resolution of certain internal issues between the device, drug, and biological centres at US FDA.

The regulation requires that the US agent act as the primary contact person for US FDA for any questions about a manufacturer and its products. US FDA defines a US agent as a person residing or maintaining a place of business in the United States. US FDA notes that the person identified must be physically present in the United States; it is not sufficient to cite a mailbox, answering machine, or answering service. The agency also suggests that the US agent be able to aid the foreign manufacturer in complying with many other US FDA requirements such as product submissions applications and mandatory reporting requirements.

"In realistic terms, while a manufacturer is not prohibited from identifying a person such as an importer, distributor, or sales and marketing organization to be its US agent, these kinds of persons are not always the best choice, since they more often do not have the expertise or experience in working with US FDA regulations," says Donald Grabarz, managing director of International Regulatory Consultants (IRC; Salt Lake City, UT, USA). IRC is a consultancy specialized in helping manufacturers of medical devices, in vitro diagnostics, and biotechnology products coordinate North American, European, and Pacific Rim regulatory and quality systems activities. The firm offers its services as a US agent.

Grabarz notes that the individual or organization selected as a US agent should be capable of providing a full range of routine regulatory services. "They should not only be able to answer questions about the manufacturer or the manufacturer's products," he says, "they should also be prepared to advise the manufacturer on regulatory issues, answer questions about compliance matters, provide administrative regulatory services, assist as needed with required submission applications for US FDA approval, provide assistance in complaint handling and mandatory reporting requirements, and act as a liaison for the manufacturer, when appropriate, with the manufacturer's importer and distribution organization."

Each foreign manufacturer must submit the name, address, and phone number of its US agent at the time it registers its establishment with US FDA. In addition, the foreign manufacturer must notify US FDA of changes in the US agent's name, address, or telephone number within 10 days of the change.

It is unclear what the penalty will be for those manufacturers that do not comply with the new regulation. Grabarz notes that US FDA could, in theory, order the US Customs Service to refuse entry of a manufacturer's product or to detain the product until the manufacturer satisfies the requirement. "This would be an easy way for FDA to enforce the requirement," he says.

Background information on the US agent requirement can be found on the US FDA Web site at www.fda.gov/cdrh/usagent. A database of individuals interested in acting as US agents for medical devices is available at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfUSagent/search.cfm. For further information, readers can contact Donald Grabarz at International Regulatory Consultants, Mid Valley Professional Plaza, 7651 S. 700 West, Ste. 105, Salt Lake City, UT 84047, USA; phone: +1 801 2330075; fax: +1 801 2330089; e-mail: grabarz@intregcon.com; Internet: www.intregcon.com.

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