mdi ConsultantsCould this be the start of the FDA rescinding the EUAs?
On October 15, 2020, the FDA reissued the EUA for certain filtering face-piece respirators (FFRs) manufactured in China which are not approved by the CDC’s National Institute for Occupational Safety and Health (NIOSH). The agency is reissuing this EUA to authorize only those types of respirators that the FDA had already authorized and are presently listed in Appendix A. This new document overrides the previous eligibility criteria, and therefore, no additional respirator models will be added using the previous guidelines. The agency understands that there are still shortages of FFRs and is continuing the EUA of respirator models already included in Appendix A.
The FDA came to this conclusion after completing a respirator shortage assessment to understand the product availability for both NIOSH-approved N95s and KN95s respirators as well as use practices for each. The KN95s authorized by this EUA meet the demand for these respirators.
To conclude, regardless of this new update, other categories of masks are unaffected. N95s from other countries are able to apply, as this only pertains to certain FFRs manufactured in China.
mdi Consultants has been predicting that the EUAs would be lifted at some point in the near future (https://mdiconsultants.com/life-after-the-eua/). If you want to continue marketing your devices in the USA after the EUAs are lifted, you will need 510(k) clearance for your MASKS, GOWNS, GLOVES, THERMOMETERS and VENTILATORS, as well as COVID 19 TESTING EUAs.
To read the full update, please visit the FDA’s website.
For any additional questions and for assistance with EUA and FDA compliance for N95s and K95s, please email mdi Consultants at [email protected] RE: EUA.