State & Federal Regulatory Compliance
FKB provides regulatory guidance for clients in dealing with many New York State government agencies, as well as the Food & Drug Administration and the Consumer Products Safety Commission. This includes legal guidance and counsel in securing approval to bring medical devices to market, overseeing consumer product testing protocols, acting as liaison between client’s and testing facilities to maintain privilege and confidentiality and providing routine updates to clients so that they remain in compliance with regulatory obligations. Our team consistently provides clients with options and can help you understand what steps you need to take throughout the process of compliance. These services allow our clients to better position themselves in the marketplace and reduce the likelihood of facing litigation.
We have assisted clients in complying with the Consumer Product Safety Improvement Act (CPSIA) of 2008. We regularly advise and assist in dealing with product reporting, product recalls and defending against assessment of civil penalties. We are sensitive to the issues that impact the day-to-day operations of manufacturing and distributing products in the face of a potential product failure and the need for maintaining confidentiality of proprietary information. We are also keenly aware of the implications reporting may have on any future product failure allegations and personal injury claims.