J. Mason Weeda's Profile Image

J. Mason Weeda

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

Mason Weeda is an associate with OFW Law and devotes his practice to a blend of regulatory and litigation matters, principally representing medical device, drug, and food manufacturers, distributors, and importers.

Mason advises clients on a wide array of topics, including, without limitation:

  • Compliance and enforcement matters involved in all facets of FDA regulation
  • FDA regulated product applications and approvals
  • FDA and USDA administrative matters, including Citizen Petitions and Trade Complaints
  • FDA and FTC promotion and advertising compliance
    • Compliance with Federal Antikickback, Sunshine, CAN-SPAM, and other laws affecting advertising and promotion of FDA-regulated products
    • Compliance with “off-label” promotion for drugs, and promotion of restricted devices
  • Import issues involving FDA and USDA regulated products, including import holds, detentions, and refusals, and CBP petitions regarding liquidated damages
  • Compliance with FDA Food regulations:
    • Food Labeling, including Nutrition Facts
    • Dietary Supplement
    • Formulation and ingredients
    • Recent Food Safety Modernization Act (FSMA) regulations, including registration and preventive controls
    • HACCP
  • Compliance with the Health Insurance Portability and Accountability Act (HIPAA), including:
    • Breach reporting of Protected Health Information
    • Audits by the Office for Civil Rights
    • Other enforcement by the Office for Civil Rights
  • Qui Tam Defense
  • Customs matters involving FDA regulated products
  • Provide regulatory advice and antitrust advice to trade association clients.
  • Regulatory due diligence opinions regarding the purchase of a FDA regulated entity or product

In addition to the above, Mason teaches Food and Drug Law to new employees at FDA’s Center for Device and Radiological Health, and is a frequent presenter at local and national symposiums and trade events. 

Mason previously worked in sales and marketing for a biologics manufacturer and a laboratory that provided neuro-genetic diagnostic testing.  After law school, he 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.  Mason then specialized in civil litigation at a boutique law firm in Maryland before joining OFW Law.  Mason’s blend of experience in sales and marketing and litigation affords him a unique and beneficial perspective in assessing and resolving regulatory matters.  

Mason was voted by his peers as a SuperLawyers “Rising Star” in Washington, DC and Maryland for 2013-2017.  

Mason was born and raised in the Washington, D.C., metropolitan area. He is a graduate of Gonzaga College High School in Washington, D.C. He later received his Bachelor of Arts degree in English from Fairfield University in 2001, and his Juris Doctorate from the University of Baltimore in 2009. Mason is a member of the Health and Agriculture Law Sections of the Maryland State Bar Association, the Food and Drug Law Institute and the American Health Lawyers Association.

Bar and Court Admissions

  • U.S. District Court District of Maryland
  • Maryland

* Practice within the District of Columbia is limited to matters and proceedings before Federal courts and agencies.

Education

  • University of Baltimore School of Law, J.D., 2009
    Student Fellow
  • Fairfield University, Fairfield, Connecticut, B.A. English, 2001
    Concentrations in Marketing and Communications

Special Agencies

  • The Food and Drug Administration
  • Health and Human Services, Office of Civil Rights
  • Federal Trade Commission
  • Department of Agriculture

Webinars and Presentations

  • “FDA Unique Device Identifier Requirements and Issues – What is Industry Facing?” (April 3, 2013)
  • “Device Changes – the Critical Components of Analyzing and Documenting the Need or No Need for an Additional 510(k)” (April 16, 2013)
  • “HITECH Business Associate Liability” (September 27, 2013)
  • “FDA Medical Device Marketing Applications 101” (October 9, 2013)
  • “FDA Regulation in Pharmacy Compounding – Risks and Critical Issues to Consider” (October 31, 2013)
  • “FDA’s Regulatory Scheme for Mobile Medical Apps 101” (November 6, 2013)
  • “FDA Enforcement Update for Medical Devices” (November 14, 2013)

Publications

  • Co-author "Bringing Your Pharmaceutical Drug to Market" FDLI (April 2015)

Honors and Awards

  • Washington D.C. Super Lawyers Rising Stars, 2013, 2014
  • Martindale-Hubbell Client Distinction Award, 2012

Browse Mason Weeda's posts on the Ag/FDA Blog