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.
Thespeaker 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
Więcej o wydarzeniu: TUTAJ
Źródło: AmCham