What are the responsibilities of the US Agent? Are US Agents responsible for compliance with medical device reporting, or MDR, regulations? Doesn't the US Initial Importer handle medical device reporting?
US Agent Services
Foreign device establishments who import devices into the United States must have a US Agent. The US Agent must reside or maintain a place of business in the United States and is responsible for:
assisting with FDA communications
responding to FDA questions
assisting with scheduling inspections, and
receiving FDA documentation in the event the foreign establishment cannot be reached.
Medical Device Reporting
Interestingly, there is some debate about whether FDA regulations impose medical device reporting responsibilities on US Agents. The FDA website itself provides that US Agents do not have MDR responsibilities. However, the Agency website does not have the force of law, meaning it doesn't govern your regulatory responsibilities, because it does not follow rulemaking procedures that must be followed to create enforceable regulations. These procedures are grounded in the concept of Procedural Due Process under the Constitution of the United States and are governed by the Administrative Procedure Act (APA). Regulations are published in the United States Code of Federal Regulations (CFR) and is the source of truth for compliance.
If we look to 21 CFR Part 803 Medical Device Reporting, there are two provisions at the heart of the debate. Part 803 discusses MDR responsibilities for user facilities, importers, and manufacturers. 21 CFR § 803.58 Foreign Manufacturers states that US Agents are responsible for medical device reporting. However, the FDA stayed § 803.58 in its Final Rule published in 2014 (pages 8845-8846), meaning it is not currently in effect. For this reason, many US Agents, and even the FDA website, say that US Agents do not have MDR responsibilities. The problem is: § 803.58 is not the only section that discusses US Agents.
The definitions in the MDR regulation are contained in § 803.3. 21 CFR § 803.3(l) states that “Manufacturer means...any person who...Is the U.S. agent of a foreign manufacturer.” In other words, every time the word “manufacturer” is used in Part 803, it applies to the US agent of a foreign manufacturer. For example, § 803.1(a) states, “If you are a manufacturer...you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device malfunctions, and you must establish and maintain adverse event files.” Because the term “manufacturer” means “the U.S. agent of a foreign manufacturer,” we must read this requirement, and all requirements applicable to manufacturers under the MDR regulation, to apply to US Agents.
What This Means For You
We can conclude that either (1) the FDA made an error when it updated the rules and failed to delete US Agents from the definition of manufacturer, or (2) whomever wrote the US Agents webpage on the FDA website has misinterpreted the regulations.
Ultimately, organizational risk-appetite will likely determine the approach to follow. In other words, more risk-averse organizations may follow the plain language of the CFR, while less risk-averse organizations may conclude the FDA website reflects the FDA's current enforcement and follow the website.
Regardless of the approach your organization chooses, QA/RA is ready to meet your needs and serve as your US Agent. We also provide Official Correspondent Services. Click here to learn more about our US Agent and Official Correspondent services.
US Initial Importer
QA/RA also provides US Initial Importer services for foreign establishments seeking to import medical devices into the United States. Without a US Initial Importer, the FDA will not release your goods for distribution into the United States and may issue a Notice of Action against you.
Device initial importers have responsibilities under 21 CFR § 803 Medical Device Reporting. There is no debate about that. They also have obligations under § 806 Reports of Corrections and Removals and, in some cases, § 821 Medical Device Tracking.
Foreign establishments can create efficiencies by partnering with QA/RA as their US Agent and Initial Importer, especially those organizations that require their US Agent to perform medical device reporting responsibilities on their behalf.