Shawn M. Schmitt
Latest From Shawn M. Schmitt
A joint final order from the US Department of Health and Human Services and the Food and Drug Administration says makers of the low-risk gloves must have 510(k) clearance before sending their products to market.
The US FDA on 22 July designated a recent recall by Royal Philips of certain bi-level positive airway pressure (BiPAP), continuous positive airway pressure (CPAP), and other mechanical ventilator devices as high-risk class I.
US FDA device center director Jeff Shuren said on 22 July that the agency is worried about the Delta variant, but is taking the steps necessary to ensure that coronavirus diagnostics give accurate readings.
Center for Devices and Radiological Health director Jeff Shuren said on 22 July that the center is incorporating lessons learned from the COVID-19 pandemic and its ongoing user-fee negotiations with industry into its upcoming set of strategic goals.
The GENOSYL DS Nitric Oxide Delivery System was recalled by Vero Biotech because the device’s software could deliver an incorrect dosage of nitric oxide, a drug used on newborns experiencing respiratory failure.
Top leaders from all commodity centers within the FDA will take part in a new Inspectional Affairs Council that’s being stood up by the agency’s Office of Regulatory Affairs. Acting commissioner Janet Woodcock will also play a role.