Due to the Coronavirus (COVID-19) pandemic, hospitals and medical facilities are overwhelmed and threaten to strain the U.S. healthcare system. Masks, ventilators, and gowns are difficult to find in the United States and hospitals are putting out desperate pleas for supplies. With people looking overseas to source these items, they need to import them in a way that satisfies rigorous U.S. import requirements and facilitates quick processing through clearance. Many of these items are regulated by the Food and Drug Administration (FDA) as medical devices and are also subject to U.S. Customs and Border Protection (CBP) regulations. The export of PPE from the United States involves the Federal Emergency Management Administration (FEMA), CBP, and other governmental entities that demand difficult and hard-to-understand policies and processes are to be satisfied.
Why should you attend:
This webinar is an important step in helping importers and exporters understand and appreciate the standards established by CBP -- the largest U.S. law enforcement agency -- the FDA and FEMA with regard to PPE – like masks/respirators, face shields, gowns, and other items considered to be medical devices.
U.S. importers and exporters must exercise extreme care when importing goods into and exporting PPE products from the United States. The failure to understand or appreciate the complex nature of CBP, FDA, FEMA, and other agency regulations can and do result in detentions and seizures, significant fines and penalties, the loss of customers, and lots of aggravation. U.S. agencies are now engaged in enforcement actions that can ruin actual and prospective importers and exporters of PPE.
Learn what PPE is equipment intended for medical use by healthcare professionals in hospitals and medical facilities; and what equipment intended for general purpose or industrial use (that is, not intended to be distributed or marketed for medical use).
Discover how to banish fear, uncertainty, and doubt with regard to the import or export of COVID-19 products. You need to know what you are doing.
Description of the topic:
The outbreak of coronavirus disease (COVID-19), first in the People’s Republic of China (PRC or China), and now globally, including in the United States, is drawing attention to the ways in which the United States and other economies depend on critical manufacturing and global value chains that rely on production based in in the PRC and other countries. Congress is particularly concerned about these dependencies and has passed legislation to better understand and address them. An area of particular concern to Congress in the current environment is U.S. shortages of medical supplies -- including personal protective equipment (PPE) and pharmaceuticals --as the United States steps up efforts to contain COVID-19 with limited domestic stockpiles and insufficient U.S. industrial capacity. PPE, antibiotics, and active pharmaceutical ingredients have led to shortages of critical medical supplies in the United States.
Importers and exporters of COVID-19 products need to know how to handle these products, avoid problems and penalties while helping those who desperately need such products.
Areas Covered in the Session:
- FDA-regulated products for medical use
- FDA classification of medical products
- CBP HTSUS classification of PPE
- FDA regulatory requirements for imported PPE
- CBP regulatory requirements for imported PPE
- National Institute for Occupational Safety and Health (NIOSH) concerns
- FDA's Emergency Use Authorization (EUA) authority
- Non-FDA regulated products for general purpose or industrial use
- China and other country export restrictions
- Defense Production Act
- CBP, FEMA and exporting PPE
- Government import and export seizures of PPE
- How to stay compliant
Who will benefit:
- exporters, business owners,
- medical doctors,
- other healthcare workers,
- and anyone involved in the import or export of COVID-19 products.