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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

FDA Targets Electronic Regulatory Submissions In Final Guidance

The US agency’s new guidance doc lays bare the types of submissions device and drug makers should send to the agency electronically.

FDA Guidance Documents

QSR Author Kim Trautman: FDA Should Change Name Of New Quality System Reg (And Other Thoughts)

The former FDAer who wrote the Quality System Regulation in the 1990s says the US agency should change the name of the rule, which has been undergoing a revision since 2018 to be harmonized with international quality systems standard ISO 13485. A name change would help delineate the retooled reg from its GMP predecessors, said Trautman, who also shared a few other thoughts about the agency’s ongoing QSR redo.

Regulation Standards

FDA Sets (Another) Deadline For Releasing Draft Harmonized Quality System Regulation

October 2020 is the new in-house target date for the US agency to release a draft of its revised QSR, which will be harmonized with international quality systems standard ISO 13485.

Regulation Standards

FDA Wants To Restart Domestic On-Site Inspections On July 20 – But There Are Caveats

US FDA commissioner Stephen Hahn said on 10 July that the agency has a plan to send investigators back into the field in 10 days. Whether or not a company is inspected, however, will depend on local COVID-19 conditions.

FDA Enforcement

US Regulatory Roundup, June 2020: FDA Talks QSR Redo; ISO Risk Standard Gets Companion Doc; Experts Predict Recalls Surge; And More

News out of the US FDA on the harmonization of its Quality System Regulation with ISO 13485, as well as stories on a new ISO technical report on risk management and a warning from experts about probable recalls because of the COVID-19 pandemic, were of most interest to our readers last month. Here are June’s 10 most popular US regulation and policy stories from Medtech Insight.

United States Regulation

Warning Letter Roundup & Recap – 7 July 2020

Luminex Corp., maker of the Verigene Processor SP System, was cited for quality systems and product recall violations. It’s one of three device-related enforcement missives released by the US FDA this week.

Device Warning Letters FDA
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