On 30th June, 2021, The US FDA removed the access for COVID-19 related Emergency Market Access for certain types of medical devices and personal protective equipment (PPE) as there has been a greater supply locally for these products. The EUA Page mentions the list of products which have been cancelled from emergency use – 

  • Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (effective July 6, 2021)
  • Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China (effective July 6, 2021)
  • Decontamination and Bioburden Reduction System EUAs for Personal Protective Equipment (effective June 30, 2021)

Cancelling these EUA’s confirms that these products can no longer be used by US Healthcare Personnel. US FDA Medical Device Regulations recommend that healthcare professionals must move towards using N95 and other respirators that have been cleared by the agency or received NIOSH approval. 

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