Many companies are utilizing emergency use authorization, or EUA, to get medical products to FDA for the U.S. marketplace. It is a great opportunity for the healthcare industry to better face emergency needs right now. An Emergency Use Authorization consulting group can assist companies addressing the pandemic needs to get the best and financially competitive medical solutions into the hands of the healthcare professionals. We offer immediate consulting services to our clients. In 2020, FDA has selected, ‘unapproved’ medical products to use in the emergency of the SARS-CoV-2 (COVID-19) pandemic to allow better treatments of serious disease or health conditions. The authorization of these products expires once FDA declares the emergency conditions ended. If products are to be manufactured after the temporary policies are lifted, they should be brought in line with regulatory compliance standards previously enforced, before COVID-19 considerations.
An EUA is a tool provided by FDA to instruct in the standards that would authorize medical products for temporary use to meet urgent medical needs; right now COVID-19. Many professionals are unfamiliar with the EUA. Emergency Use Authorization consulting services will assist you in successfully applying for the EUA. Specialists offer options to get medical products authorized with less time investment by using their experience thus far in 2020.
Get EUA consulting advice, help or submissions:
There are a number of EUAs BRG has been submitting documentation for under the 2020 COVID-19 temporary policies. These cross both drugs and devices. Do not hesitate to contact BRG for EUA assistance, including but not limited to N95 masks, medical masks, face coverings, hand sanitizers, COVID-19 testing kits (RNA, rapid, antibody), COVID-19 treatments and thermography devices.
Also Read: Hand Sanitizers 2020
The BRG EUA consulting team offers various services like product listing, FDA establishment registration, U.S. Agent representation, mask testing compilation/reviews, PPE development, hand sanitizer development, and other services. Please contact us for EUA consulting services 24 hours a day to have your project directed to proper compliance and marketing in the U.S. Prior to the EUA standards being lifted, consider a expert regulatory review and submitting your product’s documentation to comply with FDA standards when there is no longer an emergency.