Electronic Products

We provide counsel on FDA regulatory compliance matters for electronic products.

Service Areas

Our work in this area includes:

– Evaluating a product to determine whether it is a radiation-emitting electronic product and whether the product is subject to a product-specific performance standard

– Advising on applicable compliance requirements

– Assisting with the importation of radiation-emitting electronic products

– Advising on product certification requirements

Regulatory Experience

Our experience includes domestic and international business and import, and export matters regulated by FDA, CBP, USDA, and EPA.

Representative Experience

Assisted manufacturer with the importation and export of radiation-emitting electronic products
Advised company on product-specific performance standards for radiation-emitting electronic product
Filed appropriate FDA declaration for radiation-emitting electronic products

Why Work With Us?

Experienced and committed: While it helps that many of the products we advise on are ones we would use or recommend to friends and family, we are invested and care about you and the issues you are facing. We dedicate our resources to resolve your questions, and to help you reach the next peak.

Responsive: We recognize that business happens quickly. We pride ourselves on being responsive to clients, and available when you need us, whether this means accommodating international time zones or strategizing for an unannounced FDA inspection.

Client-focused: We focus on identifying the best legal and business solutions with your products and risk tolerance in mind.

Partnership: We like to view our partnership as a long-term relationship, growing with you as an extension of your regulatory team.

Specialized: Our practice is niche and our expertise is specialized. Chances are we have experience and the resources to address the regulatory questions keeping you up at night.