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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

Making Hearing Aids, Or Are They PSAPs? US FDA Offers Revised Draft Guidance To Help

Revised draft guidance document explains difference between hearing aids, regulated as medical devices, and personal sound amplification products, which aren’t. Guidance published with draft to allow hearing aids to be sold OTC.

Guidance Documents FDA

Speaking Of Medtech, Ep. 2 – Breakthrough Medical Devices

In this episode of our new deep-dive podcast Speaking Of Medtech, former US FDA device center compliance chief Steve Silverman and Medtech Insight executive editor Shawn M. Schmitt talk about the agency’s Breakthrough Devices Program – what it is, how it operates, how device makers can take full advantage of the pathway, and more.

FDA Innovation

Rust Cause: Cook Medical Recalls Medical Needles Because They Might Be Rusty

The company recalled its Transseptal Needle and Transseptal Needle with Catheter on 18 October because there could be rust on the outside or inside of the product.

Recalls Safety

Not Sure If You’re Making Hearing Aids Or PSAPs? FDA’s New Draft Guidance Should Help

A guidance document proposed by the US agency on 20 October explains the difference between hearing aids, which are regulated as medical devices, and personal sound amplification products – or PSAPs – which aren’t.

Guidance Documents FDA

No Prescription? No Problem: US FDA Draft Rule Gives Green Light To OTC Hearing Aids

FDA’s proposed rule aims to get more hearing aids into the ears of consumers who need them by allowing OTC sales of the devices. Proposal follows a a July executive order by President Biden directing HHS to issue proposed rules for OTC hearing aids within 120 days.

FDA OTC Devices

No Prescription? No Problem: FDA Draft Rule Gives Green Light To OTC Hearing Aids

The US FDA’s proposed reg, released on 19 October, aims to get more hearing aids into the ears of those who need them by allowing the devices to be purchased over the counter.

OTC Devices Regulation
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