Evan P. Phelps's Profile Image

Evan P. Phelps

Phone: (202) 789-1212
Fax: (202) 234-3550

Evan Phelps is a principal at OFW Law. He advises companies on compliance with Food and Drug Administration (FDA) law and regulations, with focus on matters related to medical devices and biologics as well as those affecting Clinical Investigators. This includes Assistance in the preparation of Premarket Approval Applications (PMAs), Premarket Notifications (510(k)s), and Investigational Device Exemption (IDE) Applications; Advice, training, and assistance with matters concerning the Quality System Regulation (QSR) and the Medical Device Reporting (MDR) Regulation; Assistance with responding to and resolving issues relating to: FDA establishment inspections, Forms FDA-483 (Inspectional Observations), Warning Letters, Recalls, Injunctions, Import/Export of FDA-regulated products, and Product labeling. Evan also assists in Clinical Investigators and IRBs with compliance, enforcement, and training issues. He advises companies on the impact of FDA law on business transactions and agreements; development of specially tailored plans to bring medical devices to market based upon client needs and goals; and assists in filing or responding to trade complaint

Evan was born in Washington, D.C., and received his B.A. from Trinity University in 1987, and his J.D. Cum Laudefrom George Mason University School of Law in 2001. He was admitted to the Virginia Bar in 2001. Prior to joining the firm, Evan was a U.S. Army Officer who served multiple tours at Fort Bragg, NC, from whence he was often sent to address matters of national interest.

Bar and Court Admissions

  • Virginia, 2001
  • District of Columbia, 2002

Education

  • Trinity University, B.A. Political Science, 1987
  • George Mason University School of Law, Juris Doctor, Cum Laude, 2001

Professional Associations

  • Regulatory Affairs Processionals Society
  • 82nd Airborne Division Association

Publications

  • Medical Device Regulation & Compliance, Food Drug and Law Institute, 2010.
  • Reporting Adverse Events: Physical Therapists and Treatment Centers Play a Role in Medical Device Safety, Advance, Vol. 20, Issue 5, 2009.
  • The Role of PTs in Medical Device Safety: Adverse Medical Device, Physical Therapy Reimbursement News, Vol. 15, No. 1, January/February, 2008.
  • The Role of the Clinician and Health Care Facility in Medical Device Safety - Adverse Medical Device Reporting, Teaching Hospitals & Academic Medical Centers, June, 2007.
  • 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.

Browse Evan Phelps' posts on the Ag/FDA Blog