Shawn M. Schmitt
Executive Editor
Latest From Shawn M. Schmitt
FDA Adds 7 New Tools To Its Regulatory Science Toolbox
The US agency has updated its Catalog of Regulatory Science Tools.
2 Deaths, 22 Injuries Lead To Class I Recall For Hillrom Overhead Lift
The US FDA has designated a recall of Hillrom’s Liko Multirall 200 Overhead Lift as high-risk class I. The recalled lifts have been manufactured since 2000.
Coronavirus Variants Spur FDA To Write New Guidance For COVID-19 Test Developers
The US agency’s immediately-in-effect guidance document – released on 22 February – explains how makers of COVID-19 diagnostics can assess whether their tests are impacted by mutations of the virus.
Déjà Vu: Boston Scientific’s Emblem Racks Up Another Class I Recall This Month
The US FDA on 19 February designated a recall of the Emblem S-ICD Subcutaneous Implantable Cardioverter Defibrillator as high-risk class I. The recall comes on the heels of a second, separate class I recall for the Emblem electrode on 2 February.
Q4 Recalls Snapshot: Fewer Devices Recalled By Industry, But Software Troubles Still Abound
Problems with software were the No. 1 reason for medical device recalls in the fourth quarter of 2020. Also: Recalls fell by a modest 3%, but the number of recalled device units mushroomed 158%. Check out our Q4 recalls infographic.
FDA Inspections All But Stopped In 2020 – But Quality-Related Warning Letters Kept On Coming
The US agency sent 21 of the letters to device makers last year – the same number it mailed to firms in 2019.