The FDA is now accepting comments from the public on the draft guidance Remanufacturing of Medical Devices and on a discussion paper on cybersecurity servicing of devices.
The White House is reviewing an FDA draft guidance that Medical Imaging & Technology Alliance officials hope will lay out strict requirements for third-party device servicers.
Pacific Medical Group is recalling the Alaris Infusion Pump Module Model 8100 because the front bezel components may crack or separate.
AK 98 offers encrypted, two-way connectivity, which enables the system to pull prescriptions directly from the EMR for simplified workflow and data handling.
This recall, linked to two patient deaths, is the third in 12 months for Medtronic’s HeartWare HVAD ventricular assist device, reports MedTech Dive.
If your company produces medical or health-related products, you need to know whether they meet the FDA’s definition of Class I medical devices—and, if so, you need to start now to implement UDI Rule requirements before enforcement begins on September 24.
FDA has issued draft guidance outlining information that should be included in pre-market submissions to demonstrate electromagnetic compatibility for electrically powered medical devices and medical devices with electrical or electronic functions.