FDA Proposes Regulations for Internal Agency Review of Device Decisions

Summary

The Food and Drug Administration (FDA) is proposing new regulations to govern internal agency review of certain decisions related to devices, aiming to align with the Food and Drug Administration Safety and Innovation Act (FDASIA) and the 21st Century Cures Act (Cures Act). This move is part of FDA's efforts to streamline regulations and reduce burdens, as mandated by Executive Orders (EOs) 13771 and 13777.