Top best Federal Regulation Lawyers in ZIP 20037 | 4 available

Mason devotes his practice to a blend of regulatory and litigation matters, principally representing medical device, biologics, pharmaceutical and food manufacturers, distributors and importers.. Mason advises clients on a wide array of topics ranging from approval and compliance of products regulated by the U.S. Food and Drug Administration to compliance with the complexities of the Health Insurance Portability and Accountability Act (HIPAA).  Mason assists clients with import issues involving FDA regulated products, including import holds, detentions, and refusals.  Consistent with his Food, Drug and Medical Device practice, Mason also provides regulatory due diligence opinions to financial institutions and other companies that may consider the purchase of a FDA regulated entity.  In addition to the above, Mason provides his trade association clients with legislative and regulatory development updates, and counsel on governance and antitrust issues.. Mason has a dynamic background that includes litigation and sales and marketing experience.  This affords him a unique and beneficial perspective in assessing and resolving regulatory matters.  Mason previously worked in sales and marketing for a biologics manufacturer and a laboratory that provided neurogenetic diagnostic testing. After graduating from law school, Mason was law clerk to The Honorable Terrence J. McGann, of the Circuit Court for Montgomery County, Maryland, where he was provided with vast exposure to litigation.  He then specialized in civil litigation at a boutique law firm in Maryland before joining OFW Law.. Mason was voted by his peers as a SuperLawyers “Rising Star” in Washington, DC and Maryland for 2013, 2014 and 2015.  He was also recognized by Martindale Hubble with the "Client Distinction Award" in 2012.. Mason was born and raised in the Washington, D.C., metropolitan area.  He is a graduate of Gonzaga College High School in Washington, DC.  He later received his Bachelor of Arts degree in English from Fairfield University in 2001, and his Juris Doctor from the University of Baltimore in 2009.  Mason is a member of the Health, Agriculture Law Sections of the Maryland State Bar Association, the Food and Drug Law Institute and the American Health Lawyers Association.

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 complaints.