The US agency issued a draft guidance that brings the 20-year old concept of "least burdensome" in medical device regulation to all corners of the device center's activities.
While US FDA's new draft guidance on the "concepts and principles" of the least burdensome provisions was prompted in part by last year's enactment of the 21st Century Cures Act, it is intended to go further than that, says device-center director Jeffrey Shuren.
"The approach that we are taking on least burdensome goes beyond what Congress has put into the law," Shuren told...
Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.
FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.
The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.
