Beyond FDA

Laws and Regulations Affecting Medical Device Promotion,
Marketing and Sale in the US

Date: 5 November 2019
Location: Bioforum, Golda Meir 3, Ness Ziona.
General Information
Duration: 1 - Day Course
Hours: 09:00 – 17:00
Price: 1,950 NIS+VAT
Credit Points: 1
SKU: 191034
Course Language: Hebrew
About the Course
Medical device manufacturers must walk an increasingly narrow line between the aggressive marketing necessary to successfully launch a new medical device in today’s competitive environment while avoiding violations of federal and state laws governing the marketing, promotion and sales of medical products in the US.
Apart from FDA post-marketing regulatory requirements, marketing, promotion and sales of medical products in the US are governed by numerous federal laws, including but not limited to) the False Claims Act, the Anti-Kickback Statute, the Federal Trade Commission Act, the Physician Payments Sunshine Act. Additionally, when patient data is associated with the use of a medical device, like a device that gathers patient data and send it to physicians, its manufacturer must ensure such data is handled in accordance with both the HITECH Act and HIPAA.

This course will provide you with an overview of the various federal laws and regulations affecting promotion, marketing and sale of medical devices in the US with emphasis on major risk areas and compliance challenges.
Who should attend
  • Medical device company personnel who work in regulatory, quality management, clinical research, medical affairs, marketing and other related areas
  • Individuals who are responsible for company, medical, promotional and investor communications
  • Individuals wishing to expand their knowledge and understanding of laws and regulations governing the advertising, marketing and sale of medical devices in the US
Beyond FDA
Benefits to the Participants
On completion of this course, participants will be able to:
  • Identify the various jurisdictions and governing agencies
  • Understand the main US federal laws affecting medical devices
  • Recognize the importance of avoiding non-compliance and their associated consequences
  • Benefit from interactive discussion and participants/instructor experience 
Contact us
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Issues to be covered
  • Brief overview of FDA post-marketing regulation, outlining the fine line where FDA jurisdiction stops, and other jurisdictions begin  
  • Introduction of the governing agencies and associated jurisdictions   
  • Overview of the main federal laws affecting medical devices (FCA, AKS, FTCA, Sunshine, HIPAA, HITECH, etc.)
  • Challenges in identifying risks and avoiding non-compliance
  • Interactive discussions of real-life case studies
About The Lecturer

Ms. Shoshana Friedman

Shoshana (Shosh) Friedman is the President and CEO of ProMedoss, Inc. Shosh has more than 28 years of experience in the fields of regulatory affairs, clinical trials, and quality assurance of medical devices and biotechnology.
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