Articles by n8n Publisher
FDA Rarely Forces Device Recalls: What Manufacturers Need to Know About Voluntary vs. Mandatory Recall Authority
By n8n Publisher |
Federal report reveals FDA rarely forces device recalls, relying on manufacturers. Learn compliance strategies for…
FDA’s Limited Use of Mandatory Medical Device Recalls: What Manufacturers Need to Know
By n8n Publisher |
Federal report reveals FDA rarely forces mandatory device recalls, relying on manufacturers. Learn compliance implications…
Medical Device Litigation Trends: What Manufacturers Need to Know About Legal Risks in 2026
By n8n Publisher |
Learn how evolving medical device litigation trends impact manufacturer compliance strategies and what proactive steps…
Insulet’s Omnipod 5 Voluntary Correction: Key Compliance Lessons for Medical Device Manufacturers
By n8n Publisher |
Insulet's voluntary Omnipod 5 correction demonstrates critical compliance lessons for medical device manufacturers in post-market…
Medical Device Recall Improvement Act of 2025: New Electronic Notification Requirements for Manufacturers
By n8n Publisher |
H.R. 6594 proposes electronic recall notifications for medical devices. Learn what manufacturers need to know…
New Congressional Push for Electronic Medical Device Recall Reporting: What Manufacturers Need to Know
By n8n Publisher |
Senators Durbin and Schakowsky propose electronic medical device recall reporting to improve transparency and speed—here's…
GAO Report Exposes Critical Gaps in FDA Medical Device Oversight: What Manufacturers Must Know
By n8n Publisher |
GAO report reveals FDA rarely mandates device recalls and relies heavily on manufacturers. Learn what…
Abiomed Impella Controller Updates: Critical Instructions for Heart Pump Safety Compliance
By n8n Publisher |
Abiomed updates Impella Controller instructions in FDA Communications Pilot, highlighting critical post-market surveillance and IFU…
FDA Communications Pilot: Calyxo Updates CVAC Aspiration System Instructions – What Manufacturers Need to Know
By n8n Publisher |
FDA launches Communications Pilot with Calyxo's CVAC aspiration system instruction update, signaling enhanced recall transparency…
Medical Device Recall Reform: New Accountability Measures and What Manufacturers Must Know
By n8n Publisher |
Medical device recall reforms propose enhanced accountability measures. Learn what manufacturers must do to prepare…
