The Federal Emergency Management Agency (FEMA) this week announced additional exemptions from a temporary final rule published in the Federal Register last year. This new notification applies beginning on June 11, 2021.

The new Federal Register notice lifts restrictions on certain exports of medical devices, including N95 respirators. However, surgical N95s are still under export restriction.

Background & ISEA Action

On April 10, 2020, FEMA published a temporary final rule to allocate certain health and medical resources for domestic use, so that these resources may not be exported from the United States without explicit approval by FEMA. In response, ISEA expressed immediate concern.

PPE manufacturers have increased supplies of respirators to domestic customers through every available pathway. Seizure of specific, specialized exports will not significantly increase domestic supply. However, disruption of international supply chains and erosion of vital business relationships will absolutely decrease the ability of domestic manufacturers to produce effectively.

– Charles Johnson, ISEA President & CEO, in a letter to DHS.


ISEA looks forward to the final notice when surgical N95s are exempt.

Read the June 14 Federal Register (Vol. 86, No. 112) here.