CDRH

FDA to Address Data Integrity Concerns with China-Based Third-Party Testing Labs

The U.S. Food and Drug Administration (FDA) is raising concerns about the integrity of data submitted by two China-based testing laboratories in support of recent premarket medical device submissions.

FDA Releases List of Proposed Guidances for FY 2025

The Center for Devices and Radiological Health at the U.S. Food and Drug Administration has published an extensive list of guidance documents that it intends to publish or develop in fiscal year 2025.

FDA Expands Advisory Program for Medical Devices Life Cycle

The Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA) has announced the expansion of its program intended to foster more efficient and expeditious development of innovative medical devices.

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What's New

FDA Seeks to Address Device Supply Chain Vulnerabilities Impacting Children

FCC Modifies Handset Unlocking Rules for Verizon

Bridging Theory and Practice: How to Implement Compliance Standards in Product Design

Davos Conference Explores Quantum Security Threats and Future of Global Digital Trust

The Backbone of EMC Testing: RF Amplifiers and Their Role in Ensuring Compliance