About Evan Phelps

Evan specializes in medical device law and has been advising and representing his clients for decades. His efforts have earned him recognition by The Best Lawyers in America® for his work.  Evan’s experience spans the breadth of the FDA’s medical device regulatory requirements from helping clients to obtain marketing authorizations, comply with ongoing regulatory controls, and providing his clients with assistance in avoiding or addressing the aftermath of an FDA enforcement action. As an advisor to start-ups, mid-sized, and large medical device manufacturers, Evan recognizes the operational and financial considerations involved in managing compliance and creating regulatory strategies.

A few examples of the type of work Evan performs for his clients includes:

• Developing FDA-compliant commercialization plans and strategies for medical devices and technologies;
• Preparing marketing applications such as 510(k)’s, De Novo submissions, and PMAs;
• Advancement of novel technologies that present novel or uncertain regulatory concerns;
• Conducting FDA compliance audits and internal investigations on behalf of clients;
• Establishing FDA-compliant complaint handling and medical device reporting systems for clients;
• Resolving compliance issues to include Warning Letters, Form FDA-483 inspectional observations, and others;
• Conducting FDA regulatory reviews of product labeling and promotional materials for compliance with FDA’s requirements;
• Guiding clients through the evaluation and reporting of adverse events and MDR reporting;
• Emergency Use Authorizations;
• Assisting with the design and execution of product recalls and the related FDA reporting requirements; and
• Conducting FDA regulatory due diligence assessments as part of mergers, acquisitions, and other business transactions.

However, Evan’s experience is not limited to medical devices and technologies. He is also an Adjunct Professor of Law at the George Mason University School of Law where he instructs future FDA regulatory attorneys on all aspects to the Federal Food, Drug, and Cosmetic Act from A to Z. In addition, Evan has also been regularly providing device-specific instruction to the people in the Center for Devices and Radiological Health (CDRH) at FDA’s request.

Evan understands both the law and the passion that his clients have for the products that they are bringing to market. From multinational firms to start-ups, companies look to Evan to provide the key guidance and assistance they need to effectively accomplish their goals in the pervasively regulated FDA sector.