CDRH Begins Reorganization Towards Team-Based Approach
CDRH has launched a major shakeup that will create several new offices—including one “super office” for product evaluation and quality. Read More
Australia Proposes New Device Classifications to Align With EU Regs
Australia’s TGA released five new draft guidances that propose changes to the classification of numerous medical devices to align more closely with European Union regulations. Read More
Devices News
CDRH Warns of Device Shortages Following Sterilizer’s Suspension
CDRH warned that more than 100 device manufacturers and hundreds of devices face potential shortages following an EPA order to stop medical equipment sterilizer Sterigenics’ Willbrook, Illinois facility from sterilizing products with eth... Read More
EMA Issues Guidance on New Device, IVD Rules
The European Medicines Agency issued final guidance on new rules for certain in vitro diagnostics and medical devices. Read More
483 Roundup: Four Device Firms Cited for GMP, Other Failures
The FDA hit four facilities for various failures including inadequate validations, CAPAs, written procedures and supplier evaluations. Read More
TGA Ends Three Year Transition to ISO 13485:2016
Australia’s Therapeutic Goods Administration reached the end of its three-year transition period to the 2016 version of ISO 13485 and devicemakers using the updated standard to show Quality Management System (QMS) conformity are now expe... Read More
