In Vivo 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
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

One Edwards Lifesciences Site Chopped Its Open CAPAs By Half. Here’s How Your Firm Can Too

Two Edwards quality experts explain to Medtech Insight how the firm is benefiting by using a new CAPA framework that shifts corrective and preventive action from a one-size-fits-all method to a more nuanced approach that separates higher-risk events from others that don’t need to be elevated to the level of a traditional CAPA.

Quality Control Compliance

Device Week, 16 October 2020 – FDA Issues 3 Guidance Docs

On this week’s podcast: The US FDA was busy with draft and final guidance documents this week, issuing three within 24 hours. The docs address disparate device industry concerns, ranging from of-the-moment issues like coronavirus test supplies, to more traditional concerns around device materials testing.

Device Week FDA

Warning Letter Roundup & Recap – 13 October 2020

Battelle Memorial Institute, which makes its Critical Care Decontamination System under emergency use authorization from the US FDA, was dinged by the agency for Medical Device Reporting violations. It’s the only device-related warning letter released by the FDA over the past week.

Device Warning Letters FDA

US FDA Recognizes Case For Quality Collaborative Community

The Case for Quality Collaborative Community – or CfQcc – affords stakeholders across industry a safe space where they can rally around an array of topics to advance medical device quality and safety.

Quality FDA

Top CDRH Officials Tell EUA Holders: Don’t Procrastinate In Getting Products FDA-Approved

Makers of devices and tests granted emergency use authorization by the US FDA are being urged by the agency to not wait until the COVID-19 public health emergency is over to get their products approved – assuming they want to keep them on the market post-pandemic.

FDA Review Pathway

FDA Stops Granting EUAs For Lab Developed Tests, Denying LDT Makers PREP Act Liability Protections

The tug of war between the US HHS and the FDA over laboratory developed tests took a surprising turn on 7 October when the agency declared that it will no longer issue emergency use authorizations for LDTs. That means unapproved COVID-19 tests that come to market without an EUA won’t be covered under the PREP Act, which protects makers of pandemic-fighting products from lawsuits.

Diagnostics FDA
See All
UsernamePublicRestriction

Register