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Medical Equipment and PPE Regulatory Reference Guide

The COVID-19 pandemic has had an unprecedented impact on the world. As healthcare providers work on the front line to combat the pandemic, the supply of ventilators, face masks and other personal protective equipment (PPE) are growing scarce. As manufacturers, many of you are in the process of supporting these ongoing needs. 

To assist you in the fight, we’ve put together this guide to share the proper protocols for U.S. regulatory submission, as provided by the FDA, CDC and ASTM, to help ensure your products get to market as quickly as possible and into the hands of our healthcare providers.

Free resources to support COVID-19

Guidance for Medical Gloves and Gowns

FDA Industry Guidance for Face Masks & Respirators

FDA Industry Guidance for Ventilators

U.S. Customs and Border Protection

Reminder: Format the correspondence in accordance with the relevant FDA guidance document to expedite response. 

For additional FDA contact information, please call: 1-888-INFO-FDA

For questions regarding the appropriate product coding, or if requesting energy use authorizations for diagnostic devices, or if requesting energy use authorizations for non-diagnostic devices, please email the FDA directly. 

For questions about how we can help with testing services, please contact us

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