Regulatory Briefs: Consensus Standards; Penalty Amounts Increase; Biologics Center Seeks Branch Chief
This article was originally published in The Gray Sheet
Executive Summary
FDA adds 53 entries to the list of standards it will recognize for device pre-market submissions, and grants de novo approval for two device types. Civil money penalty amounts increase on inflation adjustment. The Center for Biologics Evaluation and Research searches for a review branch chief. More regulatory news.