Global regulatory frameworks involving digital health technologies, particularly for the areas of medical device software including Artificial Intelligence and Machine Learning (AI/ML) are still evolving. MDIC Digital Health Program recognizes the convergence of connectivity, information and software that are revolutionizing the healthcare ecosystem, including medical device development.
Our Work Category: Medical Device Software & AI
Medical Device Software & AI facilitates data sharing, promotes the use of real-world evidence, and educates stakeholders on regulatory pathways.
Pre-determined Change Control (PCCP)
The PCCP discussed in FDA’s 2019 AI Discussion Paper and 2021 AI Action Plan enables software developers to describe anticipated modifications and the approach to their implementation in a premarket submission and implement those modifications post-market after clearance or approval without the need for further premarket review.
Software Design Considerations
FDA currently has in place a 510(k) software modification guidance that provides guidelines and a flow chart on when modifications to legally marketed devices require new premarket notification (510(k)) submissions. The 510(k) software modifications guidance is specialized to tailor the general policies to the rapid software development cycle with greater reliance on risk assessment.