JAS USA Compliance is receiving questions regarding the importing materials related to the COVID-19 pandemic.  The below information is intended to be a guide and serve as a resource for informational purposes.​

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IMPORTING PERSONAL PROTECTIVE EQUIPMENT

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When an inquiry is submitted to JAS USA Compliance regarding the importation of personal protective equipment (PPE), please provide answers to the following questions when submitting your inquiry:

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Face Mask/Respirators

• What is the intended purposes?  Medical or non-medical?  Surgical mask that provide a liquid barrier protection?
• Who is the manufacturer?
• What is the type?  N95, KN95, KN100, etc?
• Are they NIOSH Approved or Non-NIOSH approved? The approved list of NIOSH respirators can be found HERE.

Hand Sanitizer/Antibacterial Soaps

• Is it alcohol based? What is the content of the alcohol?
• Who is the manufacturer? Is the manufacturer registered with FDA?

Surface Disinfectors

• Is it the cleaner considered to be a pesticide?

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COVID-19 Test Kits

• Who is the manufacturer?

Thermometers

• Are the thermometers liquid filled or non-liquid filled?

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Surface Disinfectors

• Is it the cleaner considered to be a pesticide?

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If the inquiry is regarding any other emergency items not listed, please provide as much information about the product as possible including the manufacturer information and a complete description.

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Any further questions regarding importing COVID-19 materials can be sent to compliance@jas.com.

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RESOURCES AND FREQUENTLY REQUESTED INFORMATION

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FDA’s Subject Matter Experts

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Due to the large number of inquiries that FDA and CBP have been receiving on importing medical products under one of the guidance documents or an Emergency Use Authorization, we have set up the following email addresses for importers, manufacturers, or brokers to get direct answers.

• Diagnostic tests: COVID19DX@FDA.HHS.GOV
• Ventilators: CDRH-COVID19-Ventilators@fda.hhs.gov
• Surgical masks: CDRH-COVID19-SurgicalMasks@fda.hhs.gov
• Other personal protective equipment (PPE): CDRH-COVID19-PPE@fda.hhs.gov​
• Hand sanitizers: COVID-19-Hand-Sanitizers@fda.hhs.gov
• General import inquiries: COVID19FDAIMPORTINQUIRIES@fda.hhs.gov

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For more information, please visit the following links to FDA's COVID-19 website

• FDA COVID-19 Homepage
• Q&A for Consumers: Hand Sanitizers and COVID-19
• Animal Health & Safety and the Coronavirus Disease 2019 (COVID-19)
• Industry FAQs: Animal Food Safety and the Coronavirus Disease 2019 (COVID-19

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CSMS # 42448725 - Information for Filing Personal Protective Equipment & Medical Devices During Covid-19

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