Mr. Phelps is a principal at Olsson Frank Weeda Terman Bode Matz P.C. Mr. Phelps advises companies on compliance with Food and Drug Administration (FDA) law and regulations, with primary focus on matters related to medical devices. 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;
- Development of specially tailored plans to bring medical devices to market based upon client needs and goals; and
- Assistance in filing or responding to trade complaints.
In addition, Mr. Phelps' practice includes advising companies on matters related to compliance with Drug Enforcement Administration (DEA) law.
Mr. Phelps also serves as the General Counsel for the
Facility Certification Institute
.
Mr. Phelps was born inWashington , D.C. , received his B.A. from
Trinity University
in 1987, and his J.D. c
um laude from George Mason University School of Law in 2001. He was admitted to the
Virginia Bar
in 2001. Prior to joining the firm, Mr. Phelps was a U.S. Army Officer who served multiple tours at Fort Bragg , NC and was responsible for the conduct of several counter-narcotic operations in South and Central America.
Areas of Practice:
Food and Drug Law
Medical Device Law
Drug Enforcement Administration Law
Bar Admissions:
Virginia, 2001
District of Columbia, 2002
Evan P. Phelps 
