Medical Device Regulatory Intelligence Blog
 

The FDA approved the first device of its kind that can possibly detect if a person has COVID-19 when they are asymptomatic. This device will help prevent possible exposures to the virus, as well as slow the spread of illness. This device is used after an abnormal temperature reading. It can be used on people ages 5 and up....

Today FDA highlights that there is no transmission of COVID-19 through Food or Food Packaging based on the research and that the SARS-COV-2 is not a Food Borne Virus, such as other known viruses. At least this is one less thing to worry about in the middle of the pandemic. Overall I am grateful to our public servants in public...

US FDA has published over 95 new guidance documents in 2019 alone. See the list here: https://www.fda.gov/drugs/guidance-compliance-regulatory-information and count on Thomas Regulatory Resolutions for your medical device #consulting needs in #regulatory #qms #meddevice #medicaldevice #fda #ISO13485 #510k #medtech #usagent