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Shawn M. Schmitt

Deputy Editor

Pittsburgh, PA
Shawn M. Schmitt, deputy editor for regulatory and policy, lives and works in downtown Pittsburgh's Cultural District. For nearly 20 years he has written and edited for various high-profile media outlets, including The New Republic and London's Independent Television News (ITN). For more than a decade he has reported on medical device quality control and postmarket issues, first as Managing Editor of the now-defunct "Silver Sheet," and now in his role on "The Gray Sheet." A spirited, creative journalist, Shawn reported from the White House Rose Garden for Counseling Today, 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).
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Latest From Shawn M. Schmitt

Compliance 360° Part 3: Building Trust With US FDA – Can It Be Done?

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this third installment, former FDA investigations branch director Ricki Chase explains how your firm can build trust with agency investigators during a facility inspection.

Quality Control Compliance

New Bill Aims To Bring Consistency, Transparency To US FDA Inspections

US Sens. Johnny Isakson, R-Ga., and Michael Bennet, D-Colo., introduced legislation that calls for adopting a uniform FDA inspection process to ensure parity between audits of foreign and domestic device firms, notifying manufacturers in advance of records that will be requested during an inspection, and specifying a window of time for investigators to conduct their onsite inspections, among other requirements.

Regulation Policy

Q4 Recalls Snapshot: Numbers Dip Slightly But Remain High; Sterility Troubles Bubble To Surface

The number of device recalls fell slightly in the final quarter of 2016. While troubles with software and mislabeling continue to be a thorn in industry's side, problems with sterility popped up as the third most common reason for a product recall.

Recalls Quality Control

Compliance 360° Part 2: Getting The Most Out Of Inspection Close-Out Meetings

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this second installment, former FDA investigations branch director Ricki Chase explains steps your firm should take to make sure inspection close-out meetings are fruitful for everyone involved.

Quality Control Compliance

Adverse Events Dip Slightly In 2016; MDR Summary Reporting To US FDA Ticks Up

While the total number of device adverse events reported to the agency fell slightly last year, there was a 5% uptick in summary Medical Device Reports sent to FDA.

Quality Control Quality

Compliance 360° Part 1: Handling Difficult US FDA Investigators

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this first installment, former FDA investigations branch director Ricki Chase explains how you should handle a difficult agency investigator who shows up at your facility door.

Quality Control Compliance
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