Safe Medical Device Act of 1990 and Related Compliance Items

Title: Safe Medical Device Act of 1990 and Related Compliance Items

Presenter: Rachel V. Rose, JD, MBA – Attorney at Law

Time: 54.20 minutes

Description:
The Safe Medical Devices Act (SMDA) of 1990 established additional safeguards and reporting requirements for medical device manufacturers, importers, and user facilities. Rachel Rose, Attorney at Law, details the requirements of the SMDA and its evolution, as well as current U.S. Food and Drug Administration (FDA) AI considerations. .

Objectives:

• Review background information of the Safe Medical Devices Act of 1990.

• Appreciate the obligations of providers, manufacturers, and importers.

• Learn how to incorporate the obligations into a compliance program.

• Understand the FDA's evolving AI landscape.

• Discuss key take-aways.

   

Key Topics:

• Background
• Obligations of Providers, Manufacturers, and Importers
• Incorporating Obligations Into a Compliance Program
• The FDA's Evolving AI Landscape
• Take-Aways

 Presenter:

Rachel V. Rose, JD, MBA - Principal

Ms. Rose has a unique background. Throughout her career, she has accumulated knowledge in a multitude of fields, with an emphasis on various facets of healthcare. Her experience includes:

• Working on Wall Street and at one of the "Big Four" consulting firms
• Producing for the Chairman of the Reform and Oversight Committee on Capitol Hill
• Interning at the Department of Health and Human Services
• Compiling policy papers at the Royal College of Nursing in London
• Consultative work as a top performing representative for the pharmaceutical and medical device industry
• Clerking for the Honorable Linda R. Allan (6th Judicial Circuit, FL)

Prior to opening her law firm, Ms. Rose was Director of Business Development and Assistant General Counsel for a healthcare advisory company. 

Ms. Rose is extensively published and presents on a variety of healthcare, False Claims Act, and securities law topics, including: cybersecurity, qui tam,   physician reimbursement, ICD-10, access to care, anti-kickback and Stark laws, U.S. Supreme Court cases impacting the medical device industry, international comparative healthcare laws, and the HIPAA/the HITECH Act.