IMPORTING MEDICAL PRODUCTS
Webinar: Importing Medical Products
Webinar hosted by Ben England of Benjamin L. England Law and FDAImports.com. Helpful tips for the brokerage community regarding importing FDA-regulated products during the COVID-19 pandemic.
Ben mentioned that he didn’t have the product code for the nucleic acid test, just for the reagent. But in fact, the “kit” is a collection of reagents that will detect its analyte, so QJR is the only product code related to the emergency situation.
QJR: REAGENTS for Nucleic Acid test kits (EUA REQUIRED as part of kit) – Reg/List
Another item that Ben was asked about was related to FEMA’s guidelines about exporting PPE. The person asked if they could export PPE for the protection of their employees abroad. Actually, FEMA answered this question themselves this week! See Federal Register link under “Links of Interest”
This was specifically identified as one of the exceptions: “Intracompany Transfers of Covered Materials by U.S. Companies from Domestic Facilities to Company-owned or Affiliated Foreign Facilities.”
Links of Interest
- Ben England’s Company: FDAImports.com
- FDA: Frequently Asked Questions Page
- FDA: Medical Devices and the COVID-19 (Coronavirus) Pandemic
- FDA: Emergency Use Authorizations (EUA): PPE
- Federal Register: Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use; Exemptions