The FDA ends precertification (Pre-Cert) pilot program, saying new authority required to regulate software as a medical device (SaMD)

FDA acknowledges shortcomings of Pre-Cert pilot in report (Regulatory Focus): The US Food and Drug Administration (FDA) said it needs additional Congressional authority to move forward with its digital health precertification (Pre-Cert) program. While the idea has been widely lauded by various stakeholders, at least one expert said he feels vindicated for warning the agency early on that it lacked the legal authority to fully implement pathway. In 2017, the FDA proposed the idea of a Pre-Cert program that would act as a new pathway for software as a medical device (SaMD) products, through which the agency could green-light such products based on how much regulators trust the manufacturer. The agency has been running a pilot program to test the feasibility of the program, but in a new report, FDA concedes it does not have the legal authority needed to create the program as originally envisioned. … “We are not fully capitalizing on these capabilities and approaches for software in the current statutory and regulatory framework for medical devices,” said FDA. “Based on these observations from the pilot, FDA has found that rapidly evolving technologies in the modern medical device landscape could benefit from a new regulatory paradigm, which would require a legislative change.” “Given the challenges faced during the pilot, FDA has determined that the approach described in the Working Model is not practical to implement under our current statutory and regulatory author...
Source: SharpBrains - Category: Neuroscience Authors: Tags: Brain/ Mental Health Technology & Innovation digital health FDA Pre-Cert precertification software as a medical device US Food and Drug Administration Source Type: blogs