Business · 13/01/2022Updated: 10/17/2026 · 1 min read

FDA Issues Final Rule to Streamline Approval and Denial Announcements for Medical Devices

The US Food and Drug Administration (FDA) has introduced a new final rule to simplify the process of announcing premarket approval (PMA) and humanitarian device exemption (HDE) applications, aiming to reduce duplication and improve efficiency in the announcement of approvals and denials.