Category: FDA Updates

FDA Updates

FDA Pushes Back AED Accessory Compliance Date

FDA has changed the deadline for filing PMA applications for previously cleared AED accessories in response to the impact from COVID-19.

FDA Updates

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.

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

Philips Launches Pre-Hospital Wireless Monitoring Technology

Royal Philips has launched a wireless remote monitoring and defibrillator solution (Tempus ALS) for pre-hospital settings in the United States.

Recalls

CME America Recalls BodyGuard Infusion System Administration Sets

BD subsidiary CME America announces a voluntary recall for all CME America BodyGuard Infusion System Administration Sets—used with the company’s BodyGuard infusion pumps—that were distributed beginning May 2016.

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.