In the rapidly evolving world of medical technology, the ability to swiftly and efficiently update software is crucial. The FDAs innovative Predetermined Change Control Plan (PCCP) approach is set to revolutionize the process of making post-market software modifications to medical devices, particularly those incorporating artificial intelligence/machine learning (AI/ML) technologies. Traditional Approach vs The PCCP ApproachContinue reading “Understanding the FDA’s PCCP for Software Changes”
Tag Archives: FDORA
Revolutionizing Medical Device Software: A Look at the New FDA Guidance
On June 14, 2023 the U.S. Food and Drug Administration (FDA) finalized a new guidance document (Content of Premarket Submissions for Device Software Functions) that could be the shift in policy that marks a significant step towards modernizing and streamlining the regulatory process for medical device software, potentially leading to faster innovation and improved patientContinue reading “Revolutionizing Medical Device Software: A Look at the New FDA Guidance”
C. Austin Insight 