New

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

Conducted by: Ms. Shoshana Friedman
Print version

Share a colleague:

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...Continue reading

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.

Close
Date:  5 November, 2019
Course location: Kfar Maccabiah, Ramat Gan
Duration: 1-Day Course
Hours: 09:00 - 17:00
Credits: 1
Course Language: עברית

Course price: ₪3,900 Including VAT
Early registration is Closed
Do you have a subscription? You deserve more

Have a question? We got all the answers

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

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

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

About The Lecturer

Shoshana Friedman
Shoshana (Shosh) Friedman is the President and CEO of ProMedoss,
Read more

Leave a Reply

    [anr_nocaptcha g-recaptcha-response]