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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

Speaking Of Medtech, Ep. 6: 2022 Predictions For FDA’s Device Center

In this episode of Speaking Of Medtech we’re breaking out the crystal ball to give a few predictions of what could be in store this year for industry and the US FDA’s Center for Devices and Radiological Health. From the ongoing COVID-19 pandemic to digital devices and facility inspections, there’s a lot of ground to cover.

FDA Policy

Device Week, 14 January 2022 – Battle For The Right To Repair Devices Heats Up In US States

On this week’s podcast: From Hawaii to Missouri to Florida, the medtech industry and third-party servicers are duking it out in state legislatures over who has the right to repair and service medical devices.

Device Week Legislation

BD Veep Talks Quality Strategy And Why Your Device Firm Needs One

Manufacturers keen on fostering a culture of quality throughout their organizations should first make sure they have a robust quality strategy in place. Here, BD’s VP of quality management & supplier quality answers a handful of questions on the topic.

Quality Companies

FDA Puts Finishing Touches On Draft Guidance To Set Case For Quality VIP Program In Stone

The goal of the guidance is to make the Case for Quality Voluntary Improvement Program, or CfQ VIP, “more official” at the US FDA, an agency official says. CfQ VIP aims to elevate product, manufacturing and process quality at medical device firms.

Policy Quality

FDA: COVID-19 Antigen, Antibody Tests By LuSys Labs Could Give Wrong Results, Shouldn’t Be Used

The US FDA on 11 January issued a safety alert that the diagnostics made by LuSys Laboratories could give false-positive or false-negative results. The agency has asked health care providers and others to stop using the tests.

Safety Diagnostics

At Long Last, FDA Sends Draft Harmonized Quality System Regulation To OMB For Review

It’s been several years in the making, but the US FDA has finally sent its retooled QSR to the White House Office of Management and Budget for review. The agency has been working on harmonizing its QSR with quality systems standard ISO 13485 since 2018.

Quality Regulation
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