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.
The manufacturers failed to comply with requirements related to post approval studies and good manufacturing requirements, respectively.
Both paper and digital paper are outdated approaches to medical device quality management.
The goal of the voluntary program is to streamline the submission process. The agency also announced that it has selected participants for its EtO Innovation Challenges.