In a report to Congress dated last week, the US Food and Drug Administration (FDA) says that all of its staff involved with premarket device reviews and their supervisors have undergone mandatory training on the agency's “least burdensome” approach to regulating medical devices.
According to the report, FDA has now trained all of its 1,148 Center for Devices and Radiological Health (CDRH) and 267 Center for Biologics Evaluation and Research (CBER) staff involved with premarket device reviews on the implementation of least burdensome principles.
FDA's least burdensome provisions were first introduced under the FDA Modernization Act (FDAMA)
in 1997. Since then, both the FDA Safety and Innovation Act (FDASIA)
and the 21st Century Cures Act
have given the agency more leeway to leverage postmarket activities to offset risk when making premarketing decisions.
also called on FDA to implement mandatory training on least burdensome requirements for all staff, including supervisors, who are involved in the review of premarket device submissions.
FDA also recently issued draft guidance
on its least burdensome principles, though industry stakeholders commenting on the guidance
have called on FDA to be more clear on what those principles look like in practice. Similarly, in a report
published in January, the Government Accountability Office said that it's difficult to assess how consistent FDA's application of least burdensome principles has been.
In the report, FDA says it administered a test before and after conducting training with its device premarket review staff to gauge the effectiveness of the training.
FDA says that staff at both centers saw an improvement in knowledge of and commitment to least burdensome principles based on pre- and post-test scores. CDRH staff saw a 27.8% improvement in test scores, while staff at CBER's scores improved 7.7%.
CDRH also conducted a survey of staff 6 months after implementing the training to assess long-term impact of the training. For instance, in response to a question on how consistently staff use least burdensome concepts and principles, 75% of staff responded "always" and 25% answered "frequently".
"Overall, CDRH efforts in support of the least burdensome provisions have positively impacted the way premarket reviews are conducted," FDA writes. CBER is set to conduct a similar survey of its staff this month.
FDA also surveyed some 224 industry stakeholders on its adherence to least burdensome principles, but noted that in order to meet the statutory deadline for the report, the survey was given just two months after mandatory training was implemented.
"Feedback from the device industry appears to indicate that FDA is making progress in the application of least burdensome principles. It also indicates that there are opportunities for improvement," FDA writes.
FDA also says it has gone beyond the requirement in Cures
to train all its device premarket review staff by requiring all CDRH staff to undergo the training module and allowing all CBER staff to take the training.