Category: FDA Updates

FDA Updates

FDA Updates Medical Device Shortage List

The FDA added new supplies, including gloves and ventilators, to its medical device shortage list, as well as more information about the products.

FDA Updates

FDA 2020 Recall Roundup: A Rough Year for Infusion Pumps

Infusion pumps or their components account for nine entries in the FDA’s list of 2020 medical device recalls.

FDA Updates

Stryker Launches Voluntary Field Action for Certain Lifepak 15 Monitor/Defibrillators

Stryker announces that the company is launching a voluntary field action on specific units of their Lifepak 15 monitor/defibrillators. Specifically, the company is notifying certain Lifepak 15 customers of an issue that may cause the device to lock up after a defibrillation shock is delivered.

Clearances

GE Healthcare Receives FDA Clearance for Vivid Ultra Edition CV Ultrasound

Vivid Ultra Edition cardiovascular ultrasound features leverage AI-driven, neural network-based algorithms to deliver repeatable and faster measurements in 2D echo imaging.

Recalls

Getinge Voluntarily Recalls Servo-i Ventilator’s Nebulizer Connector

Sweden-based Getinge is announcing a voluntary medical device recall for the Servo-i ventilator system, due to a potentially shorter than specified nebulizer connector.

Labeling

Ready for the UDI Enforcement Deadline?

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.

Draft Guidances

FDA Takes Steps to Modernize 510(k) Medical Device Program

The U.S. FDA has announced that, as a first step toward implementation of the recently established Safety and Performance Based Pathway for medical devices, the agency is issuing draft guidances outlining the recommended premarket performance criteria and testing methodologies for four specific types of devices.