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The FTC Complaint Is Fully Visible. The COVID-19 'Mask' Is Not.

 
• By Malcolm Spicer

New York business partners continued false advertising for “The 1 Virus Buster Card,” to be worn around the neck or clipped onto clothing, on their website and social media platforms after receiving a warning from the US FTC in July 2020.

Covid Lies
• Source: Shutterstock

The Federal Trade Commission shows enforcement against fraudulent COVID-19 advertising isn't disappearing with a complaint against New York businessmen offering an "invisible mask" against viruses.

One of two principals of New York firm advertising K W Technology Inc. and K W Technology NV Inc., Gary...

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More from Compliance

FDA ‘Regulatory Accelerator’ Aims To Speed Digital Health Development

 
• By Elizabeth Orr

The US FDA has launched the Regulatory Accelerator to expedite digital health product development. This includes resources like a Resource Index for Innovators, a Medical Device Software Guidance Navigator, and best practices for early meetings.

Device Sterilization Plants Get Extra 2 Years To Comply On EtO Phase-Out

 
• By Elizabeth Orr

The exemption, which President Donald Trump announced on July 17, is intended to cut the risk of critical device shortages. Stakeholders say the technology needed to cut emissions to required levels is not yet widely available.

Numerous Injuries Prompt Class I Recall Of Dexcom CGM Receivers

 
• By Brian Bossetta

Dexcom has recalled several models of its glucose monitoring receivers due to a speaker glitch that may suppress vital blood sugar alerts. The FDA designated the recall, which affects thousands of devices, as class I.

Experts Call For Database Of Medical Device Labels

 
• By Elizabeth Orr

A recent JAMA column called for the US FDA to create an online database of medical device labeling, arguing that the move would increase transparency and help researchers, among other benefits. Medtech Insight discussed the idea with the paper’s lead author.

More from Policy & Regulation

Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 
• By Amanda Maxwell

In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.

HHS Suggests Drastic Reductions To Skin Substitute Payments

 
• By Elizabeth Orr

The US Department of Health and Human Services has proposed cutting Medicare reimbursement for skin substitutes used in chronic wound care by up to 90%. The change aims to address rising costs but could harm patient access and treatment quality, prompting concerns from industry stakeholders.

Injuries And Deaths Linked To Baxter Infusion Pump

 
• By Brian Bossetta

The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.