FDA Expands Early Alert Pilot Program: What Medical Device Manufacturers Need to Know
FDA expands Early Alert pilot program beyond initial five device categories, creating…
High-Risk Medical Device Recalls of 2024: Legal Consequences and Compliance Lessons
Major 2024 medical device recalls including BioZorb, Cartiva, and Impella have triggered…
FDA Issues Class I Recall for Q’Apel Medical Aspiration System: Critical Compliance Lessons for Device Manufacturers
FDA upgrades Q'Apel Medical's aspiration system recall to Class I status, affecting…
Medtronic Pipeline Vantage 027 Urgent Recall: Critical Compliance Lessons for Medical Device Manufacturers
Medtronic's urgent Pipeline Vantage 027 recall offers critical compliance lessons for medical…
FDA Updates Medline Fluid Delivery Set Alert: Key Lessons for Medical Device Manufacturers
FDA updates Medline fluid delivery set alert as part of Communications Pilot…
New Congressional Bill Could Transform Medical Device Recall Communications for Manufacturers
New bipartisan legislation could require manufacturers to use electronic recall formats and…
