Blog Entry

Changes on FDA Approval of Disposable Filtering Facepieces and China issues new rules for export of Medical Use Face Masks

In the midst of ongoing struggles to provide frontline medical personnel with N95 or Approved Medical Grade Face Masks the FDA issued an exception to their terms of authorization under the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3(b)(1)(C)) to further protect the public’s health and safety.

This exception came late last month following the review of resources available for import to the United States. As shortages for PPE remain high, the FDA issued the list of non-NIOSH approved imported disposable  Filtering Facepiece Respirators (FFRs) from specific regulatory jurisdictions, and which have been designed, evaluated, and validated to meet a given performance standard (as approved of by the FDA).

Guidelines have been set to use the FFRs in the following way, and from the corresponding areas as specified in Table 1.

  1. Authorized respirators listed in Exhibit 1 for use in healthcare settings by healthcare personnel (HCP)4 when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting from the COVID-19 outbreak.
  2. Authorized respirators listed in Exhibit 1 that have been decontaminated pursuant to the terms and conditions of an authorized decontamination system for use in healthcare settings by HCP when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting from the COVID-19 outbreak.

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Table 1. Disposable FFRs that have been designed, evaluated, and validated to meet a given performance standard and have corresponding acceptable product classifications

Like many recent temporary guidances, this exception for emergency use of specially authorized FFRs is limited to the scope of authorization set forth by the FDA and will expire as the public emergency resolves. (Download the FDA Letter to Stakeholders)

Meanwhile, as many countries struggle to find both short and long term solution to PPE and FFR shortages, China has issued some new regulations of their own. Effective April 1, 2020, China has issued Orderly Export of Medical Supplies, a temporary order which strictly regulates the export of any COVID-19 related medical devices or supplies from China. This order cover two important criteria that any device manufacturer must have in place:

  1. The device must be registered in China through a Medical Device Product Registration Certificate.
  2. The  exporter must prove that the device complies with the regulations of the importing country as they apply to that device.

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Figure 1. Joint Declaration document for importer and exporter consensus on quality and usability

While both of these regulatory items seem reasonable and in the best interest of the importing countries, it is also a huge hurdle for many Chinese manufacturers who rely on export sales to survive. It also may lessen the number of recalls and rejections of China based manufactured PPE, such as the defective masks recently recalled in the Netherlands, and the antibody test kits purchased by the Czech Republic, which reportedly only worked in certain circumstances, with nearly one third being defective all together.

Finally, it will drastically limit the number of PPE related items entering the global supply chain as demand is at its peak. As a top producer of medical devices and supplies for the global marketplace, many countries will now be faced with sourcing new import partners, and further domestic production as soon as possible to continue to provide necessary PPE such as face masks, medical protective garb, COVID test kits, ventilators and infrared thermometers.

For all US based companies currently importing PPE supplies from China, it is best to check with each manufacturer, as shipping documents have changed. Preparing for tighter regulations and presenting appropriate documentation up from may alleviate some of the delays.

Thank you to our colleagues at mdi consultants for their legwork on this story.




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