This pioneering area of technology comes with new risks and questions of liability.
Modern technology has given rise to new legal questions. How does FDA regulate machine-learning computers that are changing so rapidly – given that the approved product may be drastically different than the product that ends up on the market? These questions arise from a lack of understanding of the complex nature of AI/ML-based SaMD, the opaqueness of the regulatory framework, and a dearth of relevant case law.
With the rapid growth of life tech discoveries, there is a need to adapt the patent and regulatory frameworks governing the approval, use, and protection of such discoveries.
FDA offers help on when and what type of clinical evaluation is appropriate for SaMD.