The Time for AI-Based Medical Device Regulation Is Now

Artificial Intelligence (AI) and Machine Learning (ML) are poised to revolutionize the field of healthcare. Researchers are leveraging deep learning methods to find new ways to efficiently diagnose and treat diseases.  Although lacking a well-articulated AI strategy, the United States invested an estimated $2 billion on research and development for AI-based technologies in 2017. Since that time, the Department of Defense has also committed to providing up to an additional $2 billion per year in spending for AI technology and infrastructure over the next five years. Despite such investments, bringing an AI or similar software-based product to market is often delayed because of the hurdles involved in FDA regulatory pathways.  In recognition of this inefficiency, FDA established the Software Precertification Program, which is intended to streamline the FDA approval process for AI and ML-based medical technologies. Taking this a step further, the agency said earlier this month that it will consider a new regulatory framework for reviewing medical devices that use advanced artificial intelligence algorithms. The conventional FDA approval process for marketing new medical devices is an arduous and conservative pathway, driven by policies and procedures that are intended for hardware-based medical devices. Overall, the entire FDA medical device approval process takes an average of 3 year...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Software Source Type: news