The agency action includes all non-NIOSH-approved disposable respirators, including imported KN95s.
Automating validation processes gives manufacturers the flexibility and capability to make changes, updates and re-validation, making it easier to upgrade or add new MES modules to their process. Simplifying the process through automation leads to faster ROI and time to market.
FDA also supports the removal of the HeartWare HVAD System from the market.
The center is working to address the delays in meeting review timelines for product submissions.
The program highlights the agency’s commitment to improving safety and supporting innovation, and is a welcome counterpart to the Breakthrough Devices Program.
A product issue could cause keys to become unresponsive or stuck, leading to infusion delays.
GI Genius is based on machine learning and helps clinicians detect lesions in real time during a colonoscopy.
The Harmony Transcatheter Pulmonary Valve is an alternative to open heart surgery.
Software continues to be a key factor in recalls, and this year the end of some EUAs may also contribute to an increase.
The test generates results within 20 minutes and can be used by adults and children over the age of two years old.