FEMA originally published a Temporary Final Rule (TFR) in the Federal Register on December 31, 2020. It allocates certain scarce critical medical and healthcare resources for domestic use to ensure domestic needs are met during the COVID-19 pandemic, and to ensure supplies of certain materials are not exported abroad inappropriately. The current TFR is in effect until June 30, 2021.
As an update, effective immediately, the following are no longer restricted from export under the TFR:
- Industrial N95 Respirators, including devices that are currently NIOSH approved for use in healthcare settings under an Emergency Use Authorization (EUA) issued by the Food and Drug Administration (FDA)
- PPE Surgical Masks, as described by 21 CFR 878.4040, including masks that cover the user’s nose and mouth providing a physical barrier to fluids and particular materials, that meet fluid barrier protection standards pursuant to: ASTM F 1862; and Class I or Class II flammability tests under CPSC CS 191-53, NFPA Standard 702-1980, or UL 2154 standards
- Piston syringes that allow for the controlled and precise flow of liquid as described by 21 CFR 880.5860, that are compliant with ISO 7886-1:2017 and use only Current Good Manufacturing Practices (CGMP) processes; or
- Hypodermic single lumen needles that have engineered sharps injury protections as described in the Needlestick Safety and Prevention Act, Pub. L. 106-430, 114 Stat. 1901 (Nov. 6, 2000).