FDA CDRH Statements on Medical Device News and Regulatory Updates

This document is a collection of links to various statements and news items released by the FDA's Center for Devices and Radiological Health (CDRH) over several months. It includes announcements regarding reorganizations, new initiatives like 'Health Care at Home,' pilot programs for recalls, and guiding principles for machine learning-enabled devices. It also highlights reports, datasets, and statements on specific product safety concerns and regulatory actions, such as proposed bans and warning letters.

Compliance officers should review the linked statements relevant to their specific product lines or areas of operation. While many entries are informational, specific items like the proposed ban on electrical stimulation devices or warning letters related to plastic syringes may require immediate attention and review of internal compliance procedures. The page acts as a central point for tracking CDRH's evolving guidance and enforcement priorities.