Shawn M. Schmitt
Executive Editor
Latest From Shawn M. Schmitt
HHS/FDA Make It Official: Premarket Notification Required For 7 Types Of Class I Medical Gloves
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.
It’s Class I For June Recall Of Philips Breathing And Ventilator Devices
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.
FDA’s ‘Clearly Very Concerned’ About Delta COVID-19 Variant, CDRH’s Shuren Says
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.
US FDA’s Shuren: Device Center Will Roll Out New Strategic Priorities In 2022
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.
Recall Of Device For Critically Ill Newborns High-Risk Class I, FDA Says
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.
‘One FDA’: US Agency’s New Inspectional Affairs Council Takes Shape
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.