© [2020], NCBFAA, Washington D.C., Monday Morning eBriefing. Originally published [04/30/2020]. www.ncbfaa.orgReprinted by permission.

During a Regulatory Agencies Committee (RAC) call last week, the FDA’s Import Operations Branch Director John Verbeten told NCBFAA that the agency has pushed hard to promote wider access to Personal Protective Equipment (PPE) and other medical equipment. Recent guidance documents provide important details on how to navigate the import process. At the same time, Verbeten emphasized it is still important to understand what is being regulated. “It’s not just ‘anything goes’,” he said. Particularly for PPE and equipment intended for use in healthcare settings or by emergency responders, Verbeten advised brokers to confirm that certifications and standards are being verified by importers. Other points include: 

  • Masks intended for general public use are not regulated by FDA and can be disclaimed. This includes masks intended to be worn in factories, grocery stores or other non-healthcare workplaces, even if they are intended to protect the workers from COVID-19. Unless they are labeled as protecting against COVID-19, these masks intended for use outside a health care setting are not considered to be FDA-regulated products.
  • FDA’s big concern are masks that are destined for a health care/medical setting. This includes N95 masks labeled for medical use. With these N95 masks, brokers should follow the guidance instructions using the EUA or the discretionary enforcement policy. Importantly, the importer does not have to register as a medical device importer or file a premarket notification 510(k) – steps that are normally required for the importation of medical devices, so long as the guidance instructions are followed. Following the streamlined process outlined in the guidance and using the appropriate product code and intended use code, will help in clearing the import process.
  • Test kits face greater scrutiny. Importers must be sure ahead of time that their foreign suppliers are covered by the EUA or the discretionary enforcement policy in the guidance document. Many of the test kits are now covered by an EUA.
  • Serology test kits require pre-notification. Labels must include four specific bullet points, as noted in the guidance.

 The FDA’s latest guidance on face masks and respirators can be found here. Additional information on Emergency Use Authorizations (EUA) can be found here. All updated documentation may be found here.