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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

Philips Breathing Machines Recall: 21,000+ Adverse Events Reported To FDA In 1 Year

The tens of thousands of Medical Device Reports sent to the US agency included 124 reports of death associated with Philips’ June 2021 recall of millions of BiPAPs, CPAPs, and other mechanical ventilator devices.

Recalls Safety

FDA Launches Pilot For Makers Of Single-Use 510(k) Devices To Encourage Sterilization Switch

Under the US FDA’s voluntary 510(k) Sterility Change Master File Pilot Program, nine firms will be selected to send to the agency updated master files that detail novel sterilization processes without the need to submit a new 510(k). The goal is to move industry away from using ethylene oxide (EtO) to sterilize devices.

FDA Policy

Reminder: Time’s Running Out To Comment On FDA’s Draft Quality Management System Regulation

The deadline is 24 May to comment on one of the biggest regulatory changes in the history of the US FDA’s device center.

FDA Regulation

Toxins In Silicone Tubing Leads To FDA Warning About Hemodialysis Machines Made By Fresenius

Toxins that have been shown to cause adverse events in animals – including endocrine dysfunction and male reproductive effects – are emitted by tubing that’s part of Fresenius’ 2008T, 2008K2 and 2008K model devices, the US agency says in a letter to health care providers.

Diabetic Care Safety

FDA Draft Guidance Would Set In Stone Case For Quality Voluntary Improvement Program

The draft document from the US agency looks to officially recognize a program aimed at advancing quality in medical devices and their manufacturing.

FDA Guidance Documents

Digital Health: FDA’s Shuren Predicts ‘Critical Regulatory Hurdles’ If Congress Doesn’t Update Reg Frameworks

US FDA device center director Jeff Shuren is strongly urging lawmakers to come up with modern digital health regulatory frameworks and more strongly tackle cybersecurity issues.

Digital Health Cybersecurity
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