Establishing your medical devices through the FDA in the USA

The American Investor Desk and POLMED cordially invite you to participate in a free educational meeting called "Establishing your medical devices through the FDA in the USA" on June 22, 2021, from 3:00-4:30 p.m. Our speaker will be Rick Proctor, Managing Partner at BreakThrough Life Science Consulting; and Jeff L. Smith, President & CEO at The Braveheart Group, Inc.

The event is aimed at companies interested in the medical device sectoral branch in the United States by highlighting the navigation process of the most challenging medical devices/areas on the U.S. marketplace (i.e., software, apps, LDTs).

During the meeting, we would like to familiarize you with a brief overview of traditional U.S. pathways, software as a medical device (SaMD), mobile medical applications, laboratory-developed tests (LDTs), quality systems, intellectual property issues, government contracting, and promotional claims and practices.

Detailed agenda:

Brief Overview of Traditional U.S. Pathways

• Classes I, II, II
• De Novo
• Examples of devices for each category

Software as a Medical Device (SaMD)

• Definition statement
• Risk characterization
• Regulatory pathway
• Machine learning / artificial intelligence
• Examples

Mobile Medical Applications

• What are mobile medical apps?
• Device software functions that are the focus of FDA oversight
• Software functions for which the FDA intends to exercise "enforcement discretion"

Laboratory Developed Tests (LDTs)

• LDTs defined
• Risk-based classification
• The impact of 23andme
• Examples

Quality Systems

• FDA vs ISO 13485

Intellectual Property Issues

• Software
• Artificial intelligence

Government Contracting

• Registration requirements
• Access to contracts

Promotional Claims and Practices

• Impact on the regulatory pathway

Q&A Session