FDA Issues Guidance for Filing Personal Protective Equipment

Posted by Kelsay Calvaruso on 3/25/20 5:00 PM

On March 23, 2020, in Cargo Systems Messaging Service (CSMS) #42124872, the U.S. Food and Drug Administration (FDA) issued guidance on filing personal protective equipment (PPE) and medical devices during Covid-19.

The guidance outlines which products are regulated by FDA and when entry information is required to be provided.

  • General purpose personal protective equipment such as masks, respirators, and gloves is not regulated by FDA, and entry information is not required for FDA.
  • Products under an Emergency Use Authorization are regulated by FDA; a reduced data set is required for FDA review.
  • Devices regulated by FDA with a published enforcement discretion policy require entry information submission to FDA with an Intended Use Code of 081.006: Enforcement discretion per final guidance.

Questions regarding this guidance or for entry issues can be submitted to COVID19FDAIMPORTINQUIRIES@fda.hhs.gov or 301-796-0356.

Emergency Use Authorization requests can be submitted to FDA at: CDRH-EUA-Templates@fda.hhs.gov (for diagnostic devices) and CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov (for non-diagnostic devices).

More details including lists of products with active guidance can be found in the CSMS here:

https://content.govdelivery.com/bulletins/gd/USDHSCBP-282c648?wgt_ref=USDHSCBP_WIDGET_2

Topics: FDA, Coronavirus