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Shawn M. Schmitt
Executive Editor
Latest From Shawn M. Schmitt
Recall Of Medtronic’s HeartWare Pump Kits Labeled Class I By FDA; Deaths, Injuries Reported
The recall of the kit, which is part of the HeartWare HVAD System, was affixed with the US agency’s highest risk classification on 1 March.
FDA Misses Fifth Target Date For Issuing Draft Harmonized Quality System Reg
It’s yet another internal deadline missed by the US agency in publishing a draft of its overhauled Quality System Regulation, which is being harmonized with international quality systems standard ISO 13485.
Device Week, 26 February 2021 – Inside Integrum’s Journey To Secure FDA Approval For Novel Prosthetic
On this week’s podcast we talk about some hurdles that Swedish start-up Integrum leapt when applying for premarket approval for its Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System.
COVID-19: FDA Schedules 5 More Virtual Town Halls Through March
The US agency has announced another month of webinars aimed at labs and manufacturers that are (or have) developed diagnostic tests for the novel coronavirus.
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.