Evan Phelps

Partner

About Evan Phelps

Evan specializes in medical device law and has been advising and representing companies before FDA for nearly 20 years. 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;
• In the case of novel technologies that present novel or uncertain regulatory concerns, interfacing and meeting with the right people at FDA to get clarity and understanding;
• Conducting FDA compliance audits and internal investigations on behalf of clients;
• Establishing FDA-compliant complaint handling and medical device reporting systems for clients;
• Resolving clients’ Warning Letters, Form FDA-483 inspectional observations, and other compliance issues with FDA;
• 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;
• Applying for Emergency Use Authorizations;
• Assistance with designing and executing 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.

Articles

  • DSHEA Provisions Confine FDA's Authority to Issue Regulations That Concern Allegedly Adulterated Dietary Supplements, (Co-Author), 54 Food and Drug Law Journal 595-598, 1999.
  • The Role of the Clinician and Health Care Facility in Medical Device Safety - Adverse Medical Device Reporting, Teaching Hospitals & Academic Medical Centers, June, 2007.
  • The Role of PTs in Medical Device Safety: Adverse Medical Device, Physical Therapy Reimbursement News, Vol. 15, No. 1, January/February, 2008.
  • Reporting Adverse Events: Physical Therapists and Treatment Centers Play a Role in Medical Device Safety, Advance, Vol. 20, Issue 5, 2009.
  • Medical Device Regulation & Compliance, Food Drug and Law Institute, 2010.