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Mr. Phelps is a principal at OFW Law. Mr. Phelps 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:
In addition, Mr. Phelps' practice includes advising companies on matters related to compliance with Drug Enforcement Administration (DEA) law.
Mr. Phelps was born in Washington, 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 multiple counter-narcotic operations in South and Central America.
Areas of Practice:
Food and Drug Law
Medical Device Law
Clinical Investigation Law
Drug Enforcement Administration Law
Bar Admissions:
Virginia, 2001
District of Columbia, 2002
Education:
George Mason University School of Law, Arlington, Virginia, 2001
Juris Doctor
Honors: Cum Laude
Trinity University, San Antonio, Texas, 1987
Bachelor of Arts
Published Works:
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
Classes/Seminars Taught:
Combination Products Is it Regulated as a Drug, a Device, or Both?, FDLI & FDA 51st Annual Conference,
Washington D.C., March 2008.
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