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
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
