Based on a successful pilot program, the FDA has implemented a “least burdensome flag” program for the 510(k) clearance process as of March 4, 2019. This program allows the submitter (within 60 days) to “throw a flag” on up to two areas in the FDA’s response if they feel that the reviewers have not followed least burdensome principles:
“The FDA defines least burdensome to be the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time (e.g., need to know versus nice to know).”
While applicants are correct to be wary of the potential for their reviewer to perceive this as “going over their head” and as somewhat adversarial, it remains that the least burdensome flag is less aggressive than the appeal process itself, giving stakeholders an opportunity to ask for oversight in a manner less disruptive than a formal appeal.
The program applies to device and combination product 510(k)s. It does not apply to FDA divisions other than CDRH (Center for Devices and Radiological Health).
If you’d like to talk with one of our staff about this guidance or any part of your regulatory, technical, or manufacturing development process, please don’t hesitate to contact us.