On May 19, 2021, the U.S. Federal Emergency Management Agency (FEMA) updated its guidance for certain medical exports to remove restrictions on certain items. According to the FEMA guidance, the following products remain restricted:
- “Surgical N95 Respirators, that are single-use, disposable respiratory protective devices used in a healthcare setting that are worn by healthcare personnel during procedures to protect both the patient and HCP from the transfer of microorganisms, body fluids, and particulate material at an N95 filtration efficiency level per 42 CFR 84.181.
- PPE Nitrile Gloves, specifically those defined at 21 CFR 880.6250 (exam gloves) and 878.4460 (surgical gloves) and such nitrile gloves intended for the same purposes.
- Level 3 and 4 Surgical Gowns and Surgical Isolation Gowns that meet all of the requirements in ANSI/AAMI PB70 and ASTM F2407-06 and are classified by Surgical Gown Barrier Performance based on AAMI PB70.”
The FEMA guidance also outlines a process for exporting covered items that may be considered a “surplus”.
The current restrictions remain in effect until June 30, 2021.
The FEMA guidance can be found here:
CSMS #47857356 can be found here:
FEMA’s December 2020 Temporary Final Rule can be found here: