As labs and manufacutors are developing technologies to combat COVID-19 the following resources can assist with understanding current guidelines, testing, certification and emergency use authroization.
For testing or evaluation please contact the Evaluation and Testing Branch. Mike lmy9@cdc.gov; Sue knv2@cdc.gov; Melanie lli6@cdc.gov or 412-386-6111.
Respirator Specific Guidelines
The The National Personal Protective Technology Laboratory (NPPTL) has outlined guidelines for the following categories: (1) respirators that are beyond shelf life/stockpiled; (2) respirators entering the United States from a foreign country claiming to meet a non-NIOSH standard; and (3) respirators that are going through decontamination methods.
ASTM International has offered no-cost public access to their list of standards for masks, medical gowns, gloves, hand sanitizers, respirators and thermometers.
Industry Hotline: Coronavirus COVID-19 Diagnostic Tests and Shortages
For Industry Questions: COVID-19 Diagnostic Tests, and COVID-19 device shortages, including all Personal Protective Equipment for masks and respirators
Contact the toll-free line 24 hours a day: 1-888-INFO-FDA, choose option *
Or Email: Shortages: deviceshortages@fda.hhs.gov for Diagnostic Tests: COVID19DX@FDA.HHS.GOV.
The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.