Philip, Jennie

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:

• 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;
  • Product labeling.
• Assisting Clinical Investigators and IRBs with compliance, enforcement, and training issues.
• Advising 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
• 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 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.