The Food and Drug Administration (FDA) has recently released a draft guidance that signals a significant shift in their approach to software used in the production and quality systems of medical devices. This new guidance, titled “Computer Software Assurance for Production and Quality System Software”, emphasizes a risk-based, lifecycle approach to software assurance, moving awayContinue reading “Embracing the Shift: FDA’s New Risk-Based Approach to Non-Device Software Assurance in Medical Device Industry”
Category Archives: SDLC
Understanding the FDA’s PCCP for Software Changes
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”
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”
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