March 3, 2020: The U.S. FDA and the Centers for Disease Control and Prevention took action to make more respirators, including certain N95s, available to health care personnel. Presently, the majority of respirators on the market are indicated for use in industrial settings.

This action allows certain National Institute for Occupational Safety and Health (NIOSH) approved respirators not currently regulated by the FDA to be used in a health care setting by the health care personnel during the coronavirus (COVID-19) outbreak, thereby increasing the number of respirators available to meet the needs of the U.S. health care system.

Respiratory protective devices are designed in order to achieve a very close facial fit and competent filtration of airborne particles. When properly fitted, respirators, such as N95s, can filter more airborne particles than face masks, which is significant during an outbreak of a respiratory disease like COVID-19. The FDA regulates respirators intended for use in a health care setting, on the other hand, most respirators are used in construction and other industrial jobs only and are as a result not required to meet the FDA requirements for testing.

The FDA granted the CDC’s request for an emergency use authorization (EUA) to allow health care personnel in order to use certain industrial respirators during the COVID-19 outbreak in health care settings. The FDA concluded that respirators approved by the NIOSH, but not currently meeting the FDA’s requirements, may be efficient in preventing health care personnel from airborne exposure, including COVID-19, which can cause serious or life-threatening disease that includes severe respiratory illness.

The agencies are not currently aware of extensive shortages of personal protective equipment, but there are reports of the increased ordering of these products and shortages have been observed in some of the U.S. health care institutions. As the COVID-19 epidemic continues to expand worldwide, the FDA and CDC are conscious that the supply chain for these devices will continue to be greatly strained while demand exceeds available supplies. Regional shortages are expected in the circumstances of this emergency. The FDA and CDC are taking steps to address identified and expected shortages by increasing the use of NIOSH-approved respirators but still failing to meet FDA regulatory requirements.

Additionally, while the EUA can help by increase the availability of certain NIOSH-approved respirators to health care personnel, this EUA does not apply to the public, who should not wear these respirators to protect against COVID-19. There is no added health benefit to the general American public to wear a respiratory protective device (such as an N95 respirator). The immediate health risk from COVID-19 is considered low. The CDC recommends everyday preventive actions, such as hand washing, just to help prevent the spread of respiratory diseases.

The FDA will continue to update the public on our efforts to address this outbreak and on identifying solutions to help alleviate any supply chain problems that may occur, including continuing to evaluate the potential impacts of this outbreak on medical device availability and personal protective equipment. We are committed to working with stakeholders across the supply chain to allow access to critical medical products in close collaboration with public health and government partners.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, efficiency, and security of the human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and protection of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
https://fda.einnews.com/pr_news/511023068/coronavirus-covid-19-update-fda-and-cdc-take-action-to-increase-access-to-respirators-including-n95s-for-health-care-personnel

March 1, 2020: The FDA took new steps to expand testing for the coronavirus by allowing certain hospital laboratories in order to use their own tests before being cleared by the agency.

The action followed the complaints from academic medical centres that the previous policy — which required previous approval of the lab tests — was too heavy, too slow and also holding back efforts to diagnose patients.

Experts have warned that the small number of U.S. cases so far may be a reflection of the limited testing, not of the virus’s spread. Testing has been delayed because of problems, now being corrected, involving the only test that had been cleared by the FDA, one created by the Centers for the  Disease Control and Prevention.

Certified hospital laboratories will usually establish their own in-house tests, but the rules of a public health emergency — which now regulate coronavirus outbreak — ensure that these tests need the FDA’s “authorization for emergency use.” Under the policy announced Saturday, the laboratories will start using their own tests after validating them and before the FDA has completed their evaluations.

Therefore, hundreds of labs could soon begin testing thousands of patients.

http://fda.einnews.com/article/510939576?lcf=8DWPqPuUsDVNDakfEIxsCA%3D%3D