
FDA RECALL UPDATE: Regard Newborn Kit Recall – ROi CPS Neo-Tee T-Piece Resuscitator
Neo-Tee T-Piece resuscitator is being removed due to a undersized spring in the controller.
Neo-Tee T-Piece resuscitator is being removed due to a undersized spring in the controller.
Speed control circuit board issue that may cause the motor to be unresponsive to the user.
Use instructions updated for Varipulse ablation catheter due to a high rate of stroke or transient ischemic attack.
The consent decree restricts the production and sale of new continuous positive airway pressure (CPAP) machines, bi-level positive airway pressure (BiPAP) machines and other devices at several Philips Respironics facilities in the U.S. until certain requirements are met.
Leading hospital systems are advocating for “immediate transition” to digital communication to manage supply chain disruptions and enhance patient safety.
On May 16-17, the MedTech Regulatory Intelligence Summit will bring regulatory affairs professionals and members of the FDA together for two days of education, discussion and networking as we look at challenges and best practices in navigating current and on the horizon regulatory requirements.
The increase in global regulatory demands for medical devices has presented new challenges for regulatory affairs and intelligence teams. On May 16-17, The MedTech Regulatory Intelligence Summit will bring together regulatory professionals, device developers and regulators to look at current trends in FDA and international pre-market and post-market requirements, as well as key pain points in achieving regulatory compliance throughout the product lifecycle.
The agency is urging manufacturers to not only have recall policies in place before a recall is necessary, but to also act quickly in initiating a recall when public health is at risk.
Quarterly recall events increased for the first time since Q2 2020.
Software continues to be a key factor in recalls, and this year the end of some EUAs may also contribute to an increase.