Context

The Food and Drug Administration issued an emergency use authorization for what it said is the first device that can detect COVID-19 in breath samples.

About the device

• The InspectIR COVID-19 Breathalyzer is about the size of a piece of carry-on luggage,and can be used in doctor’s offices, hospitals and mobile testing sites. 
• The test, which can provide results in less than three minutes, must be carried out under the supervision of a licensed health care provider.
• The device was 91.2% accurate at identifying positive test samples and 99.3% accurate at identifying negative test samples.
• InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day.
• At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.

About Food and Drug Administration

• The Food and Drug Administration (FDA) is a government agency established in 1906 with the passage of the Federal Food and Drugs Act.1 
• The agency is separated into divisions that oversee a majority of the organization's obligations involving food, drugs, cosmetics, animal food, dietary supplements, medical devices, biological goods, and blood products.
• The FDA is known for its work in regulating the development of new drugs. The FDA has developed rules regarding the clinical trials that must be done on all new medications. 
• Pharmaceutical companies must test drugs through four phases of clinical trials before they can be marketed to individuals.
• The FDA is relevant for investors specifically in regards to biotech and pharmaceutical companies. 
• FDA approval can be crucial to companies that are heavily involved in developing new drugs. 
• Without the agency’s approval, regulated products under the FDA's purview cannot be released for sale in the United States.