What to Expect from FDA's Approach to Regulate Medical Software

Why Should You Attend:

In response to the rapid growth of digital healthcare, FDA has developed a streamlined regulatory pathway for approving medical software which is creating opportunities for life science and healthcare companies including pharma. FDA has advanced a regulatory framework called the Digital Health Pre-Certification (Pre-Cert) Program which is currently in a pilot testing phase. This approach aims to make reviews of digital health products more efficient by rewarding those companies who have been assessed and evaluated by the FDA as having a “robust” culture of quality and organizational excellence for the purposes of developing digital health products. Approved companies will be permitted to have their products reviewed in a streamlined manner, thereby reducing the review time for the products by focusing on what the product is rather than what it does. This would then be paired with real-world health analytics product performance analytics and user experience components, requiring the company to track how the product is being used and to quickly address issues.

Areas Covered in the Webinar:

• 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
• What are the FDA’s next steps
• Key questions about FDA’s streamlined regulatory approach
• Implications for health software industry

Who Will Benefit:

The following professionals from Life sciences companies (Pharma & Drugs; Quality Management; FDA Compliance; Medical Devices & Compliance), and Hospital & Healthcare Companies (General Healthcare; Healthcare IT & Data Security and Legal & Audits)

• 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