USA – FDA acknowledges shortcomings of Pre-Cert pilot in report

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.

In a September report, FDA notes that while its Pre-Cert pilot program allowed it to explore new techniques and approaches with industry stakeholders to oversee SaMD products, the agency faced “challenges with implementing the proposed approach under our current statutory authorities.”…