Our practice advises medical device companies of all sizes. It is the largest practice devoted solely to FDA counseling in the Southeast, with offices in Washington, D.C., and Atlanta, is known for its pragmatic, creative, and cost-efficient approach to solving problems. Its clients include medical device companies of all sizes, start-up to multinational businesses, many traded on NYSE, NASDAQ, and other foreign-trading exchanges. We work with medical device companies to identify potential regulatory and business challenges and help overcome obstacles. We partner with clients to provide value in a cost-efficient manner, balancing regulatory objectives with real-world business considerations. We help clients understand and successfully navigate the FDA regulatory process from initial clinical trial development, to product approval, product promotion, post-approval requirements and life-cycle management in addition to advising company compliance and enforcement issues.
We assist in preparing Investigational Device Exemption (IDE) applications, Premarket Notification (510(k)) submissions, and Premarket Approval (PMA) applications and related human clinical trial investigation. We also counsel on combination products and on related issues that affect the industry such as privacy, fraud and abuse, state gift reporting, import and export matters, licensing, patents, trademarks, and copyright laws.
Our lawyers are committed to the medical device industry and currently serve as founding members of Giorgia Bio (Georgia’s Life Science trade association), as teachers of food and drug law at Emory University School of Law and lecturers at programs sponsored by the Food and Drug Law Institute, Southeastern Medical Device Association and the Regulatory Affairs Professionals Society, as members of the Editorial Boards of at least three national FDA regulatory and law periodicals, and on the Board of the National Health Museum.