HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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 Preps Device Makers To Use eSTAR For De Novo Requests

Manufacturers can’t use the US FDA’s voluntary eSTAR product submission program for de novo requests until January – but they can start practicing now on how to use eSTAR for that review pathway.

FDA Review Pathway

FDA Warning Letter Prompts Company To Stop Selling Baby-Monitoring Device

For five years Owlet Baby Care Inc. has said its Smart Sock monitoring product isn’t a medical device. But the US FDA disagreed – and finally put its foot down in a warning letter that told the company to come into compliance or stop selling the sock. So Owlet decided to do both.

Pediatrics Compliance

Q3 Recalls Snapshot: Cardinal Health’s Recall Of 267 Million Syringes Causes Recalled Units To Swell

The number of recalled device units ballooned to a whopping 372,215,986 in the third quarter of 2021, mostly driven by an August recall of Monoject Flush Prefilled Saline Syringes by Cardinal Health. Check out our Q3 recalls infographic.

Recalls FDA

FDA’s New Inspections Council Whipping Up Policy Around Remote Regulatory Assessments

The US FDA says in a report that its Inspectional Affairs Council will develop Remote Regulatory Assessment policies for all commodities the agency oversees. RRAs were launched by the FDA as a way to check on a firm’s regulatory compliance without sending an investigator on-site.

Policy Enforcement

Minute Insight: HHS Gets $35M Shot In Arm To Expand Telehealth For Family Planning

The US Department of Health and Human Services said on 23 November that the money will be used “to enhance and expand the telehealth infrastructure and capacity of Title X family planning providers.”

Telehealth Policy

Infusion Pump Testing Takes Center Stage In TIR Guidance From AAMI

The Association for the Advancement of Medical Instrumentation’s new technical information report guides pump makers as they test their devices for a variety of clinical scenarios and conditions. TIR101:2021 also tackles flow rates, metrics, labeling, and more.

Standards International
See All
UsernamePublicRestriction

Register