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 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

This week, the Food & Drug Administration (FDA) made a series of announcements in connection with its efforts to address the outbreak of COVID-19.  The Agency sought to reassure the American public that the U.S. food supply remains safe and that there is no evidence of food or food packaging being associated with the transmission