U.S. Urges EU to Delay Implementing EU MDR/IVDR by Three Years
With only nine months to go before the EU’s Medical Device Regulation hits its May 26 application date, the U.S. is pressing the EU to delay implementation for another three years. Read More
IMDRF Seeks Feedback on Adverse Event Reporting Terms
The International Medical Device Regulators Forum (IMDRF) has issued a new draft document on harmonizing terminology and codes for reporting adverse events for medical devices and in vitro diagnostics. Read More
Devices News
FDA Hits Houston Devicemaker With Lengthy Warning Letter
Houston-based medical devicemaker Talon received a lengthy FDA warning letter for design process and quality control issues following an inspection of the firm’s manufacturing facility. Read More
483 Roundup: FDA Hits Four Firms for GMP, Other Failures
The FDA cited four devicemakers for problems with their complaint procedures, change controls and quality oversight, among other deficiencies. Read More
