FDA Relaxes Rules for Importation of N95 and KN95 Medical Masks

Posted on Apr 15

Medical masks used in the healthcare field have long been regulated by the FDA as medical devices and required both the manufacturer and importer of these products to meet specific requirements for the products to be allowed entry in to the U.S. Some of the requirements included Registration and Listing, manufacturing in accordance with the Quality System Regulation(QSR), medical device reporting of adverse events, and Premarket Notification 510(k) or Premarket Approval. In addition, foreign manufacturers were required to designate a United States Agent. The process was time-consuming and expensive.

Due to the outbreak of the COVID-19 virus and the shortage of much needed medical supplies, the FDA has relaxed the rules governing the importation of these products. The FDA is on record as stating that it is not their intention to impede the flow of these items. They have issued Emergency Use Authorizations (EUA) for the N95 masks, and while they specifically did not include the Chinese made KN95 masks in the EUA, they have since relaxed the rules regarding their importation as well. The FDA has warned importers that since they are currently not vetting the manufacturers of these products, they cannot verify the performance and quality of these products.

If you are importing textile face masks without a replaceable filter or mechanical parts, including surgical masks and disposable facemasks made of non-woven textiles, the applicable subheading is 6307.90.9889 and the general rate of duty is 7% ad valorem. It is important to note that these products have been excluded by the USTR from the Sec 301 List 4A additional duties of 7.5% until September 1, 2020.

As has always been the case, Personal Protective Equipment (PPE) for general purpose or industrial use (non-healthcare settings) is not regulated by the FDA.

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