Jamie represents manufacturers and distributors in obtaining approval to market medical devices, drugs, biologics, food, dietary supplements, and cosmetic products. Additionally, he counsels on all aspects of the marketing of such products, including labeling, advertising, manufacturing, and distribution. Jamie’s Food and Drug Administration (FDA) practice focuses on assisting companies with the development of FDA regulatory pathways for novel medical technologies and device combination products (device/drug and device/biologic). In addition, he assists clients with the preparation of marketing applications (PMA and 510(k)), requests for designation, and pre-Investigational Device Exemption (IDE) applications. He further counsels on post-approval/clearance issues such as product advertising, adverse event reporting, recalls, and QSR compliance. He also advises clients on matters related to Medicare reimbursement of products regulated by the FDA.
Jamie further counsels clients on their advertising, marketing, and promotional efforts. He reviews corporate advertising and marketing initiatives for federal and state legal compliance and to minimize potential liability. Jamie has represented clients in advertising disputes before the National Advertising Division of the Better Business Bureau.
Jamie also advises national retailers and manufacturers with consumer product safety issues. He counsels clients before the Consumer Product Safety Commission on compliance issues and product recalls, and he has participated in numerous product recalls. He frequently advises clients on US and international labeling and other regulatory requirements. Jamie has extensive experience advising clients on labeling and advertising for products that are subject to FDA and/or Federal Trade Commission (FTC) jurisdiction.