The FDA issued a report to Congress on the results of mandatory training given to its premarket device review staff on applying the least burdensome requirements in product reviews.
The mandatory training — which was required by the 21st Century Cures Act — instructed 1,148 CDRH and 267 CBER staff members on the implementation of least burdensome requirements, according to the audit report.
“The effort put in place to implement the Cures Act is resulting in improvements towards the appropriate application of the least burdensome concepts and principles,” the agency said.
The FDA defined least burdensome to mean the “minimum amount of information necessary to adequately address a regulatory question or issue through the most efficient manner at the right time.” The concept applies to all products that meet the statutory definition of a device and throughout the total product lifecycle, both pre and postmarket.
CDRH is anticipating requests for additional information as the premarket device review program implements the least burdensome provisions and as reviewers apply what they learn from training.
Read the FDA audit report here: www.fdanews.com/06-14-18-TrainingAudit.pdf. — James Miessler