Medical Device Recall Improvement Act of 2025: New Electronic Notification Requirements for Manufacturers
H.R. 6594 proposes electronic recall notifications for medical devices. Learn what manufacturers…
New Congressional Push for Electronic Medical Device Recall Reporting: What Manufacturers Need to Know
Senators Durbin and Schakowsky propose electronic medical device recall reporting to improve…
GAO Report Exposes Critical Gaps in FDA Medical Device Oversight: What Manufacturers Must Know
GAO report reveals FDA rarely mandates device recalls and relies heavily on…
Abiomed Impella Controller Updates: Critical Instructions for Heart Pump Safety Compliance
Abiomed updates Impella Controller instructions in FDA Communications Pilot, highlighting critical post-market…
FDA Communications Pilot: Calyxo Updates CVAC Aspiration System Instructions – What Manufacturers Need to Know
FDA launches Communications Pilot with Calyxo's CVAC aspiration system instruction update, signaling…
Medical Device Recall Reform: New Accountability Measures and What Manufacturers Must Know
Medical device recall reforms propose enhanced accountability measures. Learn what manufacturers must…
