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A recent Marketplace Tech podcast episode on the spike in demand for mental health apps caught our attention.  As shocking headlines and stay-at-home orders rolled across the country, demand for mental health apps increased almost 30% since the pandemic began, according to CNBC.  And there is a wide variety of options to choose from,

Earlier this week, federal regulators continued their efforts to combat the spread of products featuring allegedly false and misleading claims that products can diagnose, treat, cure, or prevent COVID-19.  In warning letters issued to CBD Gaze, Alternavita, Musthavemom.com, and Careful Cents LLC, the agencies identify the respective recipients as participants in

Despite the lack of a private right of action to enforce the U.S. Federal Food, Drug and Cosmetics Act (“FDCA”), the plaintiffs’ bar continually tries to use the FDCA to support other causes of action, and more often than not class actions, challenging the marketing or labeling of cosmetics.  A recent decision by the Southern

As business people, airport management, and event hosts everywhere try to figure out how they can return to business as usual, many are considering telethermographic device systems.  These are cameras that can detect human temperature in comparison to their surroundings to help identify fevers.  Reuters reported last week that Amazon implemented thermal cameras at its

FDA took action earlier this week to relax regulatory standards for gowns, hoods, and surgeons’ and patient examination gloves during the pandemic.  The policy applies to the following products:

Table 1

Classification
Regulation
Device Type Product
Code6
Class
21 CFR 878.4040 Conductive Shoe and Shoe Cover BWP I (exempt)
21 CFR 878.4040 Operating-Room Shoes

On March 25, FDA issued immediately effective guidance regarding its enforcement policy for face masks and respirators.  In light of widespread reports of mask and respirator shortages, the purpose of the guidance is to expand the availability of general use face masks for use by the general public, and of filtering facepiece respirators (N95 respirators)

FDA issued updated guidance regarding manufacture of alcohol-based hand sanitizerAs reports of hand sanitizer shortages have circulated and consumers have taken to using even Tito’s Vodka as a replacement (yes, on their hands), FDA has stepped in to provide clarity.  Last Friday, FDA issued updated guidance regarding manufacture of alcohol-based hand sanitizer.

The first guidance document, Temporary Policy for Preparation of Certain Alcohol-Based Hand

FDA Releases Industry Guidance Regarding Adverse Event Reporting During COVID-19On March 19, the Food and Drug Administration (FDA) released guidance providing recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic, including COVID-19. The guidance revises and replaces final guidance released in 2012 entitled “Postmarketing Adverse Event Reporting for Medical Products and Dietary

Last week, FDA Principal Deputy Commissioner and Acting Chief Information Officer Dr. Amy Abernethy released a series of tweets indicating that the agency is “expediting” its work towards addressing the confusion and uncertainty surrounding the regulation of hemp-derived CBD. Dr. Abernethy also stated that FDA plans to report on the agency’s progress around the end

On June 25, 2019, Senator Ron Wyden (D-OR) issued a letter urging Department of Health and Human Services (HHS) Secretary Alex Azar and Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless to take action by addressing the confusion and uncertainty surrounding the regulation of hemp-derived CBD. Specifically, Senator Wyden requested that FDA issue guidance