Devices

EPA Device Requirements

While EPA does not require device registration, EPA does regulate devices. EPA’s regulations specify which products qualify as devices, require production in an EPA establishment and require that the labeling may not bear any statements, designs, or graphic representations that are false or misleading. All device claims must be supported by scientific data and made available to EPA upon request.

EPA requires that the device label must include an EPA Establishment Number and the producer must register its establishment to obtain that number, report production annually, keep records, and subject itself to EPA inspection. Before importing a device to the United States, a Notice of Arrival must be filed with the EPA Regional office covering the port/site of entry.

In recent years we have found that Customs Officials (for imported devices) and EPA are scrutinizing device labels and claims to ensure they meet EPA requirements. Some on-line sellers (Amazon) also have been questioning device labels. EPA has been issuing enforcement advisories on devices, especially for those making antimicrobial claims. In addition, the most recent pesticide law has provided additional funds to EPA to study increased regulation of devices.

Delta Device Services

Delta carefully reviews labels for claims and other compliance details, and generally reviews efficacy data for support of claims made on the label. EPA’s requirement is that labeling not be false or misleading and data must be available to respond to states and EPA as needed. If the company does not have an establishment number, Delta can obtain an establishment number for the company. Once the label and data have been reviewed, then Delta can prepare state registration applications. For devices to be imported, Delta also can assist with Notice of Arrivals forms and working through any issues with EPA.