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FDA’s New Approach in Regulating Medical Software
- Digital revolution in healthcare
- FDA’s history in regulating medical software
- Evolution of FDA’s regulatory framework
- 21st Century Cures Act clarifies FDA jurisdiction
- Software functions excluded from medical device oversight
- Medical software as a medical device (SaMD) and software in a medical device (SiMD)
- Overview of FDA’s Digital Health Innovation Action Plan
- FDA’s Software Recertification Program and 2019 Test Plan
- Summary of FDA’s new regulatory framework
- Role of stakeholders in FDA’s revised approach
- What are FDA’s next steps
- Key questions about FDA’s streamlined regulatory approach
- Implications for the health software industry
- Can FDA’s reimagined regulatory framework for medical software products serve as a precedent for other areas of device regulation
Overview of the webinar
- As technology continues to advance in all areas of healthcare, the software has become an essential part of virtually all products, integrated widely into digital platforms that serve medical purposes
- The FDA has recognized its traditional approach to device regulation is not well suited to the explosive growth of digital health products
- FDA is experimenting with a new way to balance innovation with risk with emerging medical technologies
- FDA’s new Digital Health Innovation Plan represents a major shift from premarket to postmarket review and from government oversight to oversight by independent, nongovernmental certifiers
- Given the 21st Century Cures Act clarification of FDA's regulation of medical software plus the agency’s own initiatives, a clearer picture of how digital products may be regulated in the future is beginning to emerge
- FDA’s emerging approach raises as many questions as it answers for key stakeholders with digital health companies left with having to navigate a still uncertain and evolving regulatory path
Who should attend?
- Regulatory Directors/Managers
- Medical Software/Digital Health Company Executives & Managers
- Medical Software Design & Specification Developers
- Real-Time Software Performance Auditors
- Medical Software R&D Directors & Managers
- Business Planning Executives
- In-house Medical Software Product Legal Counsel
- Law Firm Counsels Specializing in FDA Policy
- Hospital & Healthcare Risk Managers
- Customer Support & Service Directors
Why should you attend?
- FDA has reimagined its traditional regulatory approach to medical software by establishing a new framework tailored for digital products
- The agency emerging approach to medical software product regulation has important ramifications for patients, healthcare providers and insurers as well as product developers.
- Companies throughout the life sciences and healthcare industries that utilize software in its products must understand the challenges and opportunities presented by this major policy shift
Faculty - Mr.Dennis Weissman
Dennis Weissman, A nationally recognized, independent analyst and thought leader in the diagnostic field for over three decades, Dennis is President of Dennis Weissman & Associates, LLC, Falls Church, VA, a consultancy which provides market intelligence, M&A advisory services, business leadership and public policy advice to diagnostic and life science companies and organizations. He has expertise in Medicare and health care reform policies and trends; clinical lab and pathology payment & compliance policies as well as business trends affecting the diagnostic sector. Dennis founded and served as publisher of Washington G-2 Reports (now G2 Intelligence) through 1999, an information company that reports on and analyzes the U.S. clinical laboratory industry via newsletters, research reports and conferences. Prior to G2, he served as the Director of the Washington Office of the American Society for Medical Technology (now ASCLS) and before that, Special Assistant to the Deputy Assistant Secretary for Health, Department of Health, Education & Welfare (now HHS).