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Shawn M. Schmitt

Executive Editor

Miami, FL
Executive Editor Shawn M. Schmitt lives and works in Miami. For more than two decades he has written and edited for various high-profile media outlets, including The New Republic and London's Independent Television News (ITN). Since 2005 he has reported on medical device quality control, compliance and post-market issues. A spirited, creative journalist, Shawn reported from the White House Rose Garden for Counseling Today, met with medical device experts in Costa Rica for Medtech Insight, traveled the US to get the scoop on Medicare funding for DecisionHealth, and wrote about the proliferation of nuclear weapons for National Journal's Global Security Newswire. Shawn holds a Master of Arts in Communication: Journalism and Public Affairs from American University in Washington, D.C. (2004), and a Bachelor of Arts in Journalism and Communications from Point Park University in Pittsburgh (1997).

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.

Policy FDA

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.

Recalls Safety

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.

Coronavirus COVID-19 FDA

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.

Policy FDA

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.

Recalls Safety

‘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.

FDA Enforcement
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