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Shawn M. Schmitt

Deputy Editor

Miami Beach, FL
Shawn M. Schmitt, deputy editor for regulatory and policy, lives and works in Miami Beach, Florida. 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).
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Latest From Shawn M. Schmitt

Device Week, May 18, 2018 – Medtech’s Next Top Maturity Model, Part 1

On this week's podcast, Shawn M. Schmitt talks about his first story in a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry. An ongoing US FDA pilot program – which uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) model and method – is discussed.

Device Week Quality Control

Warning Letter Roundup & Recap – May 17, 2018

German maker of the Twion Power Push-Rim Power Drive System cited for quality systems violations; RADLogics was marketing its AlphaPoint software without pre-market approval or clearance from US FDA.

Device Warning Letters FDA

'Program Alignment' Turns 1: FDA Wants To Train Investigators On Innovative Tech As Part Of Its Inspection Scheme – But Will It Be A Cakewalk?

At the one-year anniversary of "program alignment" – US FDA's ambitious reorganization of its inspectional body – the agency is pushing hard to train its investigators on an array of medtech products. In that spirit, FDA has asked manufacturers to willingly open their doors to its investigators so they can learn more about the type of devices the firms are making, says Blake Bevill, a program division director for program alignment. Industry group AdvaMed and health-care organization Medical Alley Association are also getting in on the action by helping investigators learn about an array of topics, including software, electrical engineering, validation and design.

FDA Enforcement

UPDATED: 10 Things You Need To Know About FDA's 'Program Alignment' Inspectional Reorg

Now that US FDA's "program alignment" inspection paradigm is in full swing, does your device firm know where to send an FDA-483 response? How to alert the agency about a recall? Who to contact if there is a problem with an FDA investigator? If not, then check out the answers to those questions – and seven more – in this updated feature article.

FDA Enforcement

Q1 Recalls Snapshot: Recalled Units Skyrocket 457%; Largest Quarterly Number In 13 Years

More medical devices were recalled by manufacturers in the first quarter of 2018 than in any quarter since at least 2005, with 343 initiated. Moreover, there were 208.4 million units recalled in Q1 '18 – more units than in all of 2017. Check out our Q1 recalls infographic.

Recalls Safety

US FDA Commissioner: Agency Will Propose New Rule That Blends Quality System Regulation, ISO 13485

Scott Gottlieb wrote in a May 9 blog post that the agency will propose a new rule that will blend its Quality System Regulation with international quality systems standard ISO 13485. Gottlieb claims the new rule would "harmonize domestic and international requirements, and modernize the regulation," while making sure that device-makers "adhere to high, internationally accepted quality systems."

FDA Quality Control
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